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Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults

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ClinicalTrials.gov Identifier: NCT01892189
Recruitment Status : Completed
First Posted : July 4, 2013
Results First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Ketamine-Induced Brain Activity Changes
Psychotic-like Symptoms
Interventions Drug: Ketamine
Drug: TAK-063
Drug: TAK-063 Placebo
Enrollment 27
Recruitment Details Participants took part in the study at 1 investigative site in the United States from 27 June 2013 to 28 August 2014.
Pre-assignment Details Healthy male participants were enrolled in this 3 period study and randomized in 1 of 9 administration sequences to receive TAK-063 3 mg, TAK-063 10 mg, TAK-063 30 mg and TAK-063 matching placebo. Due to predicted exposures being higher than likely clinically relevant, the dose of 300 mg was removed and replaced by 10 mg in protocol amendment 3.
Arm/Group Title Placebo + TAK-063 3 mg + TAK-063 30 mg TAK-063 3 mg + TAK-063 30 mg + Placebo TAK-063 30 mg + Placebo + TAK-063 3 mg Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg
Hide Arm/Group Description TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
Period Title: First Intervention Period (1 Day)
Started 3 3 3 3 3 3 3 3 3
Completed 3 3 3 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Washout Period 1 (7 Days)
Started 3 3 3 3 3 3 3 3 3
Completed 3 3 1 2 3 2 2 3 1
Not Completed 0 0 2 1 0 1 1 0 2
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             1
Withdrawal by Subject             0             0             2             1             0             0             1             0             1
Noncompliance, Irritability             0             0             0             0             0             1             0             0             0
Period Title: Second Intervention Period (1 Day)
Started 3 3 1 2 3 2 2 3 1
Completed 3 3 1 2 3 2 2 3 1
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Washout Period 2 (7 Days)
Started 3 3 1 2 3 2 2 3 1
Completed 3 3 1 2 3 2 2 3 1
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Third Intervention Period (1 Day)
Started 3 3 1 2 3 2 2 3 1
Completed 3 3 1 2 3 2 2 3 1
Not Completed 0 0 0 0 0 0 0 0 0
Arm/Group Title Placebo + TAK-063 3 mg + TAK-063 30 mg TAK-063 3 mg + TAK-063 30 mg + Placebo TAK-063 30 mg + Placebo + TAK-063 3 mg Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg Total
Hide Arm/Group Description TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day). Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 3 3 3 3 3 3 27
Hide Baseline Analysis Population Description
Randomized set included all participants who were randomized to either 1 of the 9 treatment sequences.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 27 participants
27.7  (3.21) 28.7  (7.64) 23.7  (6.66) 32.3  (5.13) 23  (5.20) 22.3  (3.51) 27  (7.94) 24.7  (2.08) 23.7  (5.69) 25.9  (5.60)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 27 participants
Female 0 0 0 0 0 0 0 0 0 0
Male 3 3 3 3 3 3 3 3 3 27
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 27 participants
Hispanic or Latino 0 0 0 0 0 0 1 0 0 1
Non Hispanic or Latino 3 3 3 3 3 3 2 3 3 26
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 27 participants
American Indian or Alaska Native 0 0 0 0 1 0 0 0 0 1
Asian 0 0 0 0 0 0 1 0 0 1
Multiracial 0 0 0 0 0 0 0 1 0 1
Pacific Islander-White 3 3 3 3 2 3 2 2 3 24
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 27 participants
3 3 3 3 3 3 3 3 3 27
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 27 participants
179  (2.65) 182  (4.58) 177  (8.19) 187.7  (3.79) 179.7  (10.79) 182.3  (3.06) 183.3  (8.14) 183.3  (6.51) 182.7  (4.51) 181.9  (6.06)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 27 participants
83.23  (11.981) 93.80  (4.784) 79.87  (16.910) 82.3  (12.643) 87.47  (13.955) 77.33  (8.107) 81.10  (5.821) 86.40  (4.939) 79.07  (11.716) 83.40  (10.306)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 27 participants
26.06  (4.430) 28.38  (2.557) 25.30  (3.190) 23.39  (3.844) 26.99  (2.108) 23.28  (2.611) 24.20  (2.417) 25.71  (1.011) 23.69  (3.269) 25.22  (2.997)
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 27 participants
Never smoked 3 2 3 2 3 3 2 3 2 23
Ex-smoker 0 1 0 1 0 0 1 0 1 4
Caffeine Consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 27 participants
Consumes Caffiene 2 3 3 3 2 2 3 3 3 24
Not consumes Caffiene 1 0 0 0 1 1 0 0 0 3
1.Primary Outcome
Title Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Hide Description Ketamine model was used to enhance the sensitivity to detect an effect of phosphodiesterase 10a (PDE10a) inhibition by TAK-063 by ketamine using neuroimaging battery tests. Ketamine induced robust blood oxygen level-dependent(BOLD) functional magnetic resonance imaging(fMRI) response while maintaining minimal accompanying psychotomimetic symptoms. The regions of interest include:left anterior cingulate cortex,right anterior cingulate cortex,left posterior cingulate cortex,right posterior cingulate cortex,left striatum,right striatum,left amygdala,right amygdala,left substantia nigra,right substantia nigra,left thalamus,right thalamus,left ventrolateral prefrontal cortex,right ventrolateral prefrontal cortex,left dorsolateral prefrontal cortex,right dorsolateral prefrontal cortex,left hippocampus,right hippocampus,left subgenual cingulate/Ba25,right subgenual cingulate/Ba25,left paracingulate gyrus/Ba32, and right paracingulate gyrus/Ba32.
Time Frame Day 1: 4 hours post TAK-063 dose or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacodynamic (PD) analysis set included all participants in the safety set and with at least 1 valid PD assessment. PD analysis set did not include 2 participants treated with TAK-063 300 mg.
Arm/Group Title Placebo TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg
Hide Arm/Group Description:
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
Overall Number of Participants Analyzed 22 14 14 15
Mean (Standard Deviation)
Unit of Measure: percent signal change in brain activity
Left Anterior Cingulate Cortex 0.4954  (0.53382) 0.2943  (0.67925) 0.4439  (0.72261) 0.3876  (0.47127)
Right Anterior Cingulate Cortex 0.4611  (0.44870) 0.2542  (0.55542) 0.4199  (0.70069) 0.3251  (0.47592)
Left Posterior Cingulate Cortex 0.4922  (0.52563) 0.4647  (0.52746) 0.5316  (0.77685) 0.3987  (0.49018)
Right Posterior Cingulate Cortex 0.5412  (0.52336) 0.4515  (0.57054) 0.6132  (0.79296) 0.3783  (0.55473)
Left Striatum 0.2914  (0.40513) 0.0644  (0.47601) 0.3045  (0.51442) 0.2453  (0.40828)
Right Striatum 0.3605  (0.37202) 0.1154  (0.52174) 0.3124  (0.46817) 0.2617  (0.36033)
Left Amygdala 0.3413  (0.66866) 0.4776  (0.72631) 0.4888  (0.60449) 0.3435  (0.57560)
Right Amygdala 0.2102  (0.72431) 0.1180  (0.85125) 0.0106  (0.76838) 0.2686  (0.53395)
Left Substantia Nigra 0.3989  (0.49787) 0.2857  (0.61851) 0.5560  (0.67716) 0.2214  (0.36486)
Right Substantia Nigra 0.2925  (0.45514) 0.2209  (0.69383) 0.3398  (0.45331) 0.1148  (0.40258)
Left Thalamus 0.5166  (0.40051) 0.3406  (0.58293) 0.5564  (0.52695) 0.3589  (0.43768)
Right Thalamus 0.4807  (0.35272) 0.3392  (0.59598) 0.5159  (0.44482) 0.3734  (0.44173)
Left Ventrolateral Prefrontal Cortex 0.6355  (0.79768) 0.5183  (0.66695) 0.6081  (0.73306) 0.5900  (0.47920)
Right Ventrolateral Prefrontal Cortex 0.7932  (0.59179) 0.5134  (0.69396) 0.6661  (0.75274) 0.6119  (0.44821)
Left Dorsolateral Prefrontal Cortex 0.3918  (0.41983) 0.2576  (0.56173) 0.4451  (0.62506) 0.3720  (0.30576)
Right Dorsolateral Prefrontal Cortex 0.4715  (0.40803) 0.2799  (0.53268) 0.5403  (0.78105) 0.4331  (0.39160)
Left Hippocampus 0.3150  (0.37531) 0.1790  (0.47311) 0.3073  (0.41116) 0.2123  (0.35146)
Right Hippocampus 0.2540  (0.27489) 0.1814  (0.51038) 0.2141  (0.34537) 0.0989  (0.35725)
Left Subgenual Cingulate/BA25 -0.3974  (1.60367) 0.2236  (1.22450) -0.2448  (1.46965) -0.0002  (2.18015)
Right Subgenual Cingulate/BA25 -0.1463  (1.55680) -0.3430  (1.15319) -0.6379  (2.30349) 0.0424  (1.71727)
Left Paracingulate Gyrus/BA32 0.4776  (0.43067) 0.2799  (0.59577) 0.4069  (0.65537) 0.3281  (0.38990)
Right Paracingulate Gyrus/BA32 0.5849  (0.51897) 0.3583  (0.58987) 0.4972  (0.82842) 0.3969  (0.52267)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using analysis of variance (ANOVA) model with sequence, period, regimen and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.259
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -0.2348
Confidence Interval (2-Sided) 95%
-0.6506 to 0.1809
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20458
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.869
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0367
Confidence Interval (2-Sided) 95%
-0.4853 to 0.4119
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22075
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.306
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2180
Confidence Interval (2-Sided) 95%
-0.6441 to 0.2081
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20968
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.169
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2525
Confidence Interval (2-Sided) 95%
-0.6174 to 0.1124
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17956
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.831
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0417
Confidence Interval (2-Sided) 95%
-0.4354 to 0.3521
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19375
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.197
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2421
Confidence Interval (2-Sided) 95%
-0.6161 to 0.1319
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.18403
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.480
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1155
Confidence Interval (2-Sided) 95%
-0.4443 to 0.2133
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16180
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.345
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1673
Confidence Interval (2-Sided) 95%
-0.1875 to 0.5221
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17458
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.371
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1504
Confidence Interval (2-Sided) 95%
-0.4874 to 0.1866
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16583
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.364
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1731
Confidence Interval (2-Sided) 95%
-0.5553 to 0.2092
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.18808
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.507
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1362
Confidence Interval (2-Sided) 95%
-0.2762 to 0.5486
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20294
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.210
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2464
Confidence Interval (2-Sided) 95%
-0.6381 to 0.1453
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19276
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3059
Confidence Interval (2-Sided) 95%
-0.5955 to -0.0162
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14253
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.931
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0134
Confidence Interval (2-Sided) 95%
-0.2991 to 0.3260
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15380
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.431
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1164
Confidence Interval (2-Sided) 95%
-0.4133 to 0.1804
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14608
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3269
Confidence Interval (2-Sided) 95%
-0.5985 to -0.0554
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13362
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.562
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0845
Confidence Interval (2-Sided) 95%
-0.3775 to 0.2085
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14418
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.216
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1727
Confidence Interval (2-Sided) 95%
-0.4510 to 0.1056
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13695
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.962
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0084
Confidence Interval (2-Sided) 95%
-0.3663 to 0.3495
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17609
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.852
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0357
Confidence Interval (2-Sided) 95%
-0.4218 to 0.3505
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19001
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.241
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2154
Confidence Interval (2-Sided) 95%
-0.5822 to 0.1514
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.18048
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.443
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1380
Confidence Interval (2-Sided) 95%
-0.4991 to 0.2230
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17766
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.295
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2037
Confidence Interval (2-Sided) 95%
-0.5933 to 0.1859
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19170
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.743
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0602
Confidence Interval (2-Sided) 95%
-0.4303 to 0.3098
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.18209
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1774
Confidence Interval 95%
-0.5040 to 0.1491
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16068
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.758
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0539
Confidence Interval (2-Sided) 95%
-0.4062 to 0.2985
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17338
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4377
Confidence Interval (2-Sided) 95%
-0.7724 to -0.1031
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16468
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.490
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1037
Confidence Interval (2-Sided) 95%
-0.4055 to 0.1981
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14849
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.534
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1007
Confidence Interval (2-Sided) 95%
-0.4263 to 0.2249
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16023
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.169
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2140
Confidence Interval (2-Sided) 95%
-0.5233 to 0.0953
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15219
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2641
Confidence Interval (2-Sided) 95%
-0.5510 to 0.0228
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14118
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.579
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0854
Confidence Interval (2-Sided) 95%
-0.3950 to 0.2242
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15234
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2446
Confidence Interval (2-Sided) 95%
-0.5387 to 0.0494
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14470
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2200
Confidence Interval (2-Sided) 95%
-0.4950 to 0.0550
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13533
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0527
Confidence Interval (2-Sided) 95%
-0.3495 to 0.2440
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14603
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.196
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1830
Confidence Interval (2-Sided) 95%
-0.4649 to 0.0989
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13870
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.313
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2051
Confidence Interval (2-Sided) 95%
-0.6122 to 0.2020
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20032
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.908
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0253
Confidence Interval (2-Sided) 95%
-0.4140 to 0.4646
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21616
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3042
Confidence Interval (2-Sided) 95%
-0.7214 to 0.1131
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20531
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3409
Confidence Interval (2-Sided) 95%
-0.7066 to 0.0249
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17997
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.739
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0652
Confidence Interval (2-Sided) 95%
-0.4599 to 0.3294
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19419
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4163
Confidence Interval (2-Sided) 95%
-0.7912 to -0.0415
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.18445
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2032
Confidence Interval (2-Sided) 95%
-0.4952 to 0.0888
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14369
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.552
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0932
Confidence Interval (2-Sided) 95%
-0.2219 to 0.4083
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15504
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.271
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1648
Confidence Interval (2-Sided) 95%
-0.4641 to 0.1345
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14727
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2516
Confidence Interval (2-Sided) 95%
-0.5802 to 0.0770
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16169
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.468
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1279
Confidence Interval (2-Sided) 95%
-0.2266 to 0.4825
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17447
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.228
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2033
Confidence Interval (2-Sided) 95%
-0.5401 to 0.1334
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16572
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.141
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2000
Confidence Interval (2-Sided) 95%
-0.4696 to 0.0696
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13268
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.964
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0065
Confidence Interval (2-Sided) 95%
-0.2975 to 0.2844
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14317
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1935
Confidence Interval (2-Sided) 95%
-0.4699 to 0.0828
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13599
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.285
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1446
Confidence Interval (2-Sided) 95%
-0.4152 to 0.1260
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13315
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 53 Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.903
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0176
Confidence Interval (2-Sided) 95%
-0.3096 to 0.2744
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14368
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 54 Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.245
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1615
Confidence Interval (2-Sided) 95%
-0.4388 to 0.1159
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13647
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 55 Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.429
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3659
Confidence Interval (2-Sided) 95%
-0.5630 to 1.2948
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.45708
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 56 Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.937
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0395
Confidence Interval (2-Sided) 95%
-0.9628 to 1.0419
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.49321
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 57 Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.101
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7902
Confidence Interval (2-Sided) 95%
-0.1618 to 1.7423
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.46847
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 58 Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.321
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4404
Confidence Interval (2-Sided) 95%
-1.3296 to 0.4488
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.43756
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 59 Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4685
Confidence Interval (2-Sided) 95%
-1.4280 to 0.4910
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.47214
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 60 Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.356
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4200
Confidence Interval (2-Sided) 95%
-0.4914 to 1.3314
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.44846
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 61 Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32. Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2254
Confidence Interval (2-Sided) 95%
-0.5666 to 0.1158
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16790
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 62 Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.899
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0232
Confidence Interval (2-Sided) 95%
-0.3914 to 0.3449
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.18117
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 63 Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2534
Confidence Interval (2-Sided) 95%
-0.6032 to 0.0963
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17208
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
Show Statistical Analysis 64 Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 3 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA3: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2821
Confidence Interval (2-Sided) 95%
-0.6690 to 0.1048
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19038
Estimation Comments Difference between least square means of TAK-063 3 mg and Placebo.
Show Statistical Analysis 65 Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 10 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.817
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0480
Confidence Interval (2-Sided) 95%
-0.4655 to 0.3695
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20543
Estimation Comments Difference between least square means of TAK-063 10 mg and Placebo.
Show Statistical Analysis 66 Hide Statistical Analysis 66
Statistical Analysis Overview Comparison Group Selection Placebo, TAK-063 30 mg
Comments Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3395
Confidence Interval (2-Sided) 95%
-0.7361 to 0.0570
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19513
Estimation Comments Difference between least square means of TAK-063 30 mg and Placebo.
2.Secondary Outcome
Title Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite (M-I)
Hide Description [Not Specified]
Time Frame Day 1: pre-dose and at multiple time points (up to 24 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.
Arm/Group Title TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg
Hide Arm/Group Description:
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
Overall Number of Participants Analyzed 14 14 15
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
TAK-063 10.35  (2.860) 48.16  (8.769) 109.9  (27.053)
M-I 12.07  (3.235) 48.94  (11.500) 103.72  (32.635)
3.Secondary Outcome
Title Tmax: Time to Reach Cmax for TAK-063 and TAK-063 M-I
Hide Description [Not Specified]
Time Frame Day 1: pre-dose and at multiple time points (up to 24 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.
Arm/Group Title TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg
Hide Arm/Group Description:
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
Overall Number of Participants Analyzed 14 14 15
Median (Full Range)
Unit of Measure: hours
TAK-063
3.02
(0.5 to 6.0)
3.03
(2.0 to 5.8)
3.02
(2.0 to 5.8)
M-I
2.96
(1.9 to 4.3)
3.03
(2.0 to 5.7)
4.23
(2.0 to 6.0)
4.Secondary Outcome
Title AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 M-I
Hide Description [Not Specified]
Time Frame Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.
Arm/Group Title TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg
Hide Arm/Group Description:
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
Overall Number of Participants Analyzed 14 14 15
Mean (Standard Deviation)
Unit of Measure: nanogram hours per milliliter (ng*hr/mL)
TAK-063 111.36  (38.460) 548.58  (122.686) 1298.89  (331.095)
M-I 114.81  (48.453) 582.91  (201.503) 1285.18  (499.431)
5.Secondary Outcome
Title Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Hide Description [Not Specified]
Time Frame Baseline up to 14 days after last dose of study drug (Day 32)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Placebo TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg TAK-063 300 mg
Hide Arm/Group Description:
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
Overall Number of Participants Analyzed 22 14 14 15 2
Measure Type: Number
Unit of Measure: percentage of participants
68.2 50 57.1 86.7 100
6.Secondary Outcome
Title Percentage of Participants Who Meet the Takeda Global Research and Development Center, Inc. (TGRD) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Hide Description The percentage of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Time Frame Baseline up to 14 days after last dose of study drug (Day 32)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Placebo TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg TAK-063 300 mg
Hide Arm/Group Description:
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
Overall Number of Participants Analyzed 22 14 14 15 2
Measure Type: Number
Unit of Measure: percentage of participants
9.1 0 14.3 6.7 0
7.Secondary Outcome
Title Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Hide Description The percentage of participants who meet markedly abnormal criteria designated by TGRD. Vital signs included oral temperature, respiration, blood pressure and pulse (beats per minute).
Time Frame Baseline up to 14 days after last dose of study drug (Day 32)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Placebo TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg TAK-063 300 mg
Hide Arm/Group Description:
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
Overall Number of Participants Analyzed 22 14 14 15 2
Measure Type: Number
Unit of Measure: percentage of participants
50.0 64.3 57.1 53.3 100
8.Secondary Outcome
Title Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Hide Description The percentage of participants who meet markedly abnormal criteria designated by TGRD measured throughout study.
Time Frame Baseline up to 14 days after last dose of study drug (Day 32)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Placebo TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg TAK-063 300 mg
Hide Arm/Group Description:
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
Overall Number of Participants Analyzed 22 14 14 15 2
Measure Type: Number
Unit of Measure: percentage of participants
27.3 14.3 35.7 53.3 100
Time Frame Baseline up to 14 days after last dose of study drug (Day 32)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Placebo TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg TAK-063 300 mg
Hide Arm/Group Description TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3. TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3. TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3. TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3. TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
All-Cause Mortality
Placebo TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg TAK-063 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg TAK-063 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/14 (0.00%)   0/14 (0.00%)   0/15 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo TAK-063 3 mg TAK-063 10 mg TAK-063 30 mg TAK-063 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/22 (68.18%)   7/14 (50.00%)   8/14 (57.14%)   13/15 (86.67%)   2/2 (100.00%) 
Eye disorders           
Diplopia  1  0/22 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/2 (0.00%) 
Gastrointestinal disorders           
Vomiting  1  10/22 (45.45%)  3/14 (21.43%)  6/14 (42.86%)  8/15 (53.33%)  1/2 (50.00%) 
Nausea  1  6/22 (27.27%)  2/14 (14.29%)  3/14 (21.43%)  2/15 (13.33%)  0/2 (0.00%) 
Dry Mouth  1  0/22 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/2 (0.00%) 
Retching  1  2/22 (9.09%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/2 (0.00%) 
General disorders           
Fatigue  1  3/22 (13.64%)  1/14 (7.14%)  4/14 (28.57%)  0/15 (0.00%)  0/2 (0.00%) 
Infections and infestations           
Upper Respiratory Tract Infection  1  0/22 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/2 (0.00%) 
Pharyngitis  1  1/22 (4.55%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back Pain  1  0/22 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/2 (0.00%) 
Muscle Tightness  1  0/22 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  1/2 (50.00%) 
Nervous system disorders           
Somnolence  1  2/22 (9.09%)  1/14 (7.14%)  4/14 (28.57%)  7/15 (46.67%)  1/2 (50.00%) 
Headache  1  1/22 (4.55%)  2/14 (14.29%)  1/14 (7.14%)  0/15 (0.00%)  0/2 (0.00%) 
Dizziness  1  1/22 (4.55%)  0/14 (0.00%)  0/14 (0.00%)  2/15 (13.33%)  0/2 (0.00%) 
Dysarthria  1  0/22 (0.00%)  1/14 (7.14%)  1/14 (7.14%)  0/15 (0.00%)  0/2 (0.00%) 
Lethargy  1  0/22 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/2 (0.00%) 
Paraesthesia  1  0/22 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/2 (0.00%) 
Coordination Abnormal  1  1/22 (4.55%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/2 (0.00%) 
Hypoaesthesia  1  1/22 (4.55%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/2 (0.00%) 
Syncope  1  1/22 (4.55%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/2 (0.00%) 
Psychiatric disorders           
Disorientation  1  1/22 (4.55%)  2/14 (14.29%)  1/14 (7.14%)  0/15 (0.00%)  0/2 (0.00%) 
Restlessness  1  0/22 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  1/2 (50.00%) 
Communication Disorder  1  0/22 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/2 (0.00%) 
Confusional State  1  0/22 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/2 (0.00%) 
Insomnia  1  0/22 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/2 (0.00%) 
Vascular disorders           
Pallor  1  0/22 (0.00%)  1/14 (7.14%)  3/14 (21.43%)  2/15 (13.33%)  0/2 (0.00%) 
Hot Flush  1  1/22 (4.55%)  0/14 (0.00%)  1/14 (7.14%)  1/15 (6.67%)  0/2 (0.00%) 
Hypotension  1  0/22 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (V 17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No publication related to study results will be made without Sponsor’s prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01892189     History of Changes
Other Study ID Numbers: TAK-063_102
U1111-1141-2177 ( Other Identifier: World Health Organization )
First Submitted: June 20, 2013
First Posted: July 4, 2013
Results First Submitted: November 11, 2016
Results First Posted: January 12, 2017
Last Update Posted: January 12, 2017