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Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

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ClinicalTrials.gov Identifier: NCT02013531
Recruitment Status : Completed
First Posted : December 17, 2013
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Anxiety
Intervention Drug: Brexpiprazole
Enrollment 37
Recruitment Details This trial was conducted in 37 participants. 18 trial sites were initiated in the United Sates, and 12 trial sites enrolled participants.
Pre-assignment Details The trial consisted of a 2- to 21-day screening phase, a 6-week (42-day) treatment phase, and a 30-day (+ 2) follow-up phase.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Participants were administered oral brexpiprazole tablets of 0.5 milligram per day (mg/day) with titration up to 3 mg/day once daily (QD) in addition to their constant-dose ADT (anti-depressant therapy) for 6 weeks.
Period Title: Overall Study
Started 37
Completed 32
Not Completed 5
Reason Not Completed
Lost to Follow-up             3
Met Withdrawal Criteria             1
Withdrawal by Subject             1
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
45.7  (15.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
26
  70.3%
Male
11
  29.7%
1.Primary Outcome
Title Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, with higher values indicating worse outcome.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid Baseline and Post-Baseline efficacy assessment. A mixed model repeated measures (MMRM) analysis was performed.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-19.6  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments The null hypothesis of zero in mean change from Baseline in the MADRS total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM with model terms: Baseline, visit, and Baseline by visit interaction
2.Secondary Outcome
Title Mean Change in Clinical Global Impression-Severity (CGI-S) Total Score
Hide Description The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. A MMRM analysis was performed.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.2  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments Statistical analysis at Week 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction
3.Secondary Outcome
Title Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 6.
Hide Description The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.9  (1.1)
4.Secondary Outcome
Title Percentage of Participants With CGI-I Response Rate
Hide Description The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.
Time Frame Week 1 to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 8.3
Week 2 36.1
Week 3 50.0
Week 4 66.7
Week 6 75.0
5.Secondary Outcome
Title Percentage of Participants With a MADRS Response
Hide Description MADRS response rate, where response is defined as ≥ 50% reduction in respective total scores from Baseline to Week 6. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, higher values indicate worse outcome.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: Percentage of participants
69.4
6.Secondary Outcome
Title Percentage of Participants With a MADRS Remission
Hide Description MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Baseline to Week 6. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, higher values indicate worse outcome.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: Percentage of participants
47.2
7.Secondary Outcome
Title Mean Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score
Hide Description The HAM-D17 was utilized as an assessment of a participants level of depression and was administered utilizing the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D). Detailed instructions for administration of this structured interview were provided in the SIGH-D. The HAM-D17 was administered at the following visits: screening, Baseline, and Week 6/ Early termination (ET). HAM-D17 is a 17-item questionnaire with a total score of 0 to 52 with higher scores indicating more depressive symptoms.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-15.85  (7.37)
8.Secondary Outcome
Title Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Hide Description The HAM-A was utilized for the evaluation of anxiety symptoms and was administered using the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). Detailed instructions for administration of this structured interview were provided in the SIGH-A. The HAM-A was administered at the following visits: screening, Baseline, Weeks 1, 2, 3, 4, and 6/ET. HAM-A is a 14-item scale with each item is scored on a scale from 0 (not present) to 4 (very severe) with a total score of 0 to 56, with higher scores indicating severe anxiety symptoms.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. A MMRM analysis was performed.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-17.80  (1.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole
Comments The null hypothesis of zero in Mean change from Baseline in HAM-A total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction
9.Secondary Outcome
Title Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
Hide Description The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.62  (2.60)
10.Secondary Outcome
Title Mean Change From Baseline in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score
Hide Description The MGH-CPFQ was a participant-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The MGH-CPFQ consisted of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranged from 7 to 42, with higher scores indicative of a worse outcome. The MGH-CPFQ was administered at the following visits: Baseline and Week 6/ET.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-9.85  (8.79)
11.Secondary Outcome
Title Mean Change From Baseline in Kellner Symptom Questionnaire (KSQ)
Hide Description KSQ is a subject-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility and somatization. The questionnaire contains 92 items of which 68 items indicate symptoms and 24 items are antonyms of some of the symptoms that indicate well-being. The maximum score for each symptom subscale is 17, the well-being subscales 6 and for the total scale scores 23. A higher score indicates more distress than a lower score. The total subscale scores will be unevaluable if less than 19 of the 23 items are recorded. If 19 to 22 of the 23 items are recorded, the total subscale score is the mean of the recorded items multiplied by 23 and then rounded to the first decimal place. The total score will be unevaluable if less than 76 of the 92 items are recorded. If 76 to 91 of the 92 items and no less than 19 of the 23 items of each subscale are recorded, the total score will be the mean of the recorded items multiplied by 92 and then rounded to the first decimal place.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-29.43  (20.88)
12.Secondary Outcome
Title Mean Change From Baseline in Go/No-Go Task for P-inhibition Failures
Hide Description Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. The instrument was administered at the following visits: Baseline and Week 6/ET.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: failures
P-inhibition failures (Go cues) -0.0193  (0.2324)
P-inhibition failures (No-Go cues) -0.0103  (0.2337)
13.Secondary Outcome
Title Mean Change From Baseline in Go/No-Go Task for Mean Reaction Time
Hide Description Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. The instrument was administered at the following visits: Baseline and Week 6/ET.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: milliseconds
Mean reaction time (Go cues) -0.26  (52.49)
Mean reaction time (No-Go cues) -4.26  (51.69)
14.Secondary Outcome
Title Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Score
Hide Description Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, "would you prefer $27 today or $50 in 21 days?") The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: unitless
-0.008442  (0.060200)
15.Secondary Outcome
Title Mean Change From Baseline in Delay and Probability Discounting Task (DPDT) Scores
Hide Description The experiential discounting task (EDT) was a subject-completed computerized task designed to measure delay discounting, an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value: value = A / (1 + hO) p is probability of reward and O is odds against. The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher probability discounting shows greater impulsivity). A total score is not computed for this task.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: unitless
Delay discounting task k value -3.586888  (15.156644)
Probability discouting task h value 3.505900  (28.036537)
16.Secondary Outcome
Title Mean Change From Baseline to Week 6 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)
Hide Description Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Number of Impulsive Choices
4.6  (18.1)
17.Secondary Outcome
Title Mean Change From Baseline in Food Delay Discounting Task
Hide Description Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the "X-axis" is "days", "Y-axis" is "Food value", the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting).
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: unitless
0.0371  (0.1819)
18.Secondary Outcome
Title Mean Change From Baseline in Money Delay Discounting Task
Hide Description Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the "X-axis" is "days", "Y-axis" is "Money value", the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting).
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: unitless
0.0707  (0.2284)
19.Secondary Outcome
Title Mean Change From Baseline in Barratt Impulsiveness Scale 11-item (BIS-11) Total Score
Hide Description The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. The BIS-11 was administered at the following visits: Baseline and Week 6/ET.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-7.67  (10.14)
Time Frame Adverse events were reported from the signing of the informed consent until the follow-up visit of 30 (+2 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Participants were administered oral brexpiprazole tablets of 0.5 mg/day to 3 mg/day, QD for 6 weeks.
All-Cause Mortality
Brexpiprazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brexpiprazole
Affected / at Risk (%)
Total   1/37 (2.70%) 
Infections and infestations   
Pneumonia * 1  1/37 (2.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brexpiprazole
Affected / at Risk (%)
Total   28/37 (75.68%) 
Gastrointestinal disorders   
Diarrhoea * 1  4/37 (10.81%) 
Dry mouth * 1  4/37 (10.81%) 
General disorders   
Fatigue * 1  2/37 (5.41%) 
Infections and infestations   
Influenza * 1  2/37 (5.41%) 
Metabolism and nutrition disorders   
Increased appetite * 1  5/37 (13.51%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/37 (5.41%) 
Musculoskeletal stiffness * 1  3/37 (8.11%) 
Neck pain * 1  2/37 (5.41%) 
Nervous system disorders   
Akathisia * 1  2/37 (5.41%) 
Dizziness * 1  4/37 (10.81%) 
Headache * 1  2/37 (5.41%) 
Paraesthesia * 1  2/37 (5.41%) 
Psychiatric disorders   
Insomnia * 1  2/37 (5.41%) 
Irritability * 1  2/37 (5.41%) 
Restlessness * 1  2/37 (5.41%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02013531     History of Changes
Other Study ID Numbers: 331-13-002
First Submitted: December 6, 2013
First Posted: December 17, 2013
Results First Submitted: August 4, 2015
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016