Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression (PREVAIL3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01284517
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : October 14, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bipolar Depression
Interventions Drug: Lurasidone
Drug: Placebo
Enrollment 356
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lurasidone 20-120 mg Flexible Dose+Li/VPA Placebo + Li/VPA
Hide Arm/Group Description Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex Placebo + Lithium/divalproex
Period Title: Overall Study
Started 180 176
Completed 148 140
Not Completed 32 36
Arm/Group Title Lurasidone 20-120 mg Flexible Dose+Li/VPA Placebo + Li/VPA Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 176 166 342
Hide Baseline Analysis Population Description
This is the full analysis set (intent-to-treat population)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 166 participants 342 participants
<=18 years
3
   1.7%
0
   0.0%
3
   0.9%
Between 18 and 65 years
166
  94.3%
161
  97.0%
327
  95.6%
>=65 years
7
   4.0%
5
   3.0%
12
   3.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants 166 participants 342 participants
43.1  (11.90) 44.1  (11.99) 43.6  (11.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 166 participants 342 participants
Female
91
  51.7%
93
  56.0%
184
  53.8%
Male
85
  48.3%
73
  44.0%
158
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants 166 participants 342 participants
United States 71 63 134
Czech Republic 9 8 17
Slovakia 17 21 38
Canada 9 8 17
Ukraine 17 14 31
Lithuania 10 9 19
Peru 6 7 13
Colombia 12 10 22
Japan 5 4 9
India 20 22 42
1.Primary Outcome
Title Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
Hide Description MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Time Frame Baseline to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (intent-to-treat population)
Arm/Group Title Lurasidone 20-120 mg Flexible Dose+Li/VPA Placebo + Li/VPA
Hide Arm/Group Description:
Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
Placebo (PO) + Lithium or divalproex
Overall Number of Participants Analyzed 176 166
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-11.8  (0.76) -10.4  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurasidone 20-120 mg Flexible Dose+Li/VPA, Placebo + Li/VPA
Comments Null hypothesis (H0) assumes equal values between analysis groups in mean change from baseline in MADRS score, alternative hypothesis (HA) assumes unequal values between groups. Sample size determined by two-sample t-test. A mean difference of 3.25 units in change in MADRS score for the Lurasdone 20-120 mg arm over placebo with common standard deviation of 9 units was used. N=162 subjects per arm (total N=324) yields power of 90%. A 5% adjustment for drop-outs gives N=340, or N=170 per arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.08
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Hide Description CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Time Frame Baseline to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (intent-to-treat population)
Arm/Group Title Lurasidone 20-120 mg Flexible Dose+Li/VPA Placebo + Li/VPA
Hide Arm/Group Description:
Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
Placebo (PO) + Lithium or divalproex
Overall Number of Participants Analyzed 176 166
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.36  (0.099) -1.13  (0.102)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurasidone 20-120 mg Flexible Dose+Li/VPA, Placebo + Li/VPA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.141
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Hide Description SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Time Frame Baseline to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (intent-to-treat population)
Arm/Group Title Lurasidone 20-120 mg Flexible Dose+Li/VPA Placebo + Li/VPA
Hide Arm/Group Description:
Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
Placebo (PO) + Lithium or divalproex
Overall Number of Participants Analyzed 176 166
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.4  (0.85) -5.4  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurasidone 20-120 mg Flexible Dose+Li/VPA, Placebo + Li/VPA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.992
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.00
Estimation Comments [Not Specified]
Time Frame 13 December 2010 to 7 August 2012
Adverse Event Reporting Description Adverse event data (including number of participants at risk) is presented for the safety population, defined as subjects with exposure to at least one dose of study medication.
 
Arm/Group Title Lurasidone 20-120 mg Flexible Dose+Li/VPA Placebo + Li/VPA
Hide Arm/Group Description Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex Placebo (PO)+ Lithium/divalproex
All-Cause Mortality
Lurasidone 20-120 mg Flexible Dose+Li/VPA Placebo + Li/VPA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lurasidone 20-120 mg Flexible Dose+Li/VPA Placebo + Li/VPA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/177 (2.82%)      3/171 (1.75%)    
General disorders     
Disease Progression  1  1/177 (0.56%)  1 0/171 (0.00%)  0
Immune system disorders     
Anaphylactic Shock  1  1/177 (0.56%)  1 0/171 (0.00%)  0
Injury, poisoning and procedural complications     
Intentional Overdose  1  1/177 (0.56%)  1 0/171 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Flank Pain  1  0/177 (0.00%)  0 1/171 (0.58%)  1
Nervous system disorders     
Transient Ischemic Attack  1  0/177 (0.00%)  0 1/171 (0.58%)  1
Psychiatric disorders     
Depression  1  1/177 (0.56%)  1 0/171 (0.00%)  0
Suicidal Ideation  1  1/177 (0.56%)  1 0/171 (0.00%)  0
Depression Suicidal  1  1/177 (0.56%)  1 0/171 (0.00%)  0
Mania  1  0/177 (0.00%)  0 1/171 (0.58%)  1
Skin and subcutaneous tissue disorders     
Angioedema  1  1/177 (0.56%)  1 0/171 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lurasidone 20-120 mg Flexible Dose+Li/VPA Placebo + Li/VPA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/177 (44.63%)      63/171 (36.84%)    
Gastrointestinal disorders     
Nausea  1  18/177 (10.17%)  25 16/171 (9.36%)  20
Diarrhoea  1  14/177 (7.91%)  15 10/171 (5.85%)  13
Nervous system disorders     
Akathisia  1  25/177 (14.12%)  29 9/171 (5.26%)  12
Headache  1  15/177 (8.47%)  18 15/171 (8.77%)  16
Somnolence  1  15/177 (8.47%)  16 5/171 (2.92%)  6
Tremor  1  11/177 (6.21%)  14 9/171 (5.26%)  9
Dizziness  1  9/177 (5.08%)  9 9/171 (5.26%)  9
Psychiatric disorders     
Insomnia  1  15/177 (8.47%)  16 18/171 (10.53%)  19
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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.
In addition to the <60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; provided, if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.
Results Point of Contact
Name/Title: Medical Director, CNS
Organization: Sunovion
Phone: 1-866-503-6351
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01284517     History of Changes
Other Study ID Numbers: D1050292
2010-019778-34 ( EudraCT Number )
First Submitted: January 25, 2011
First Posted: January 27, 2011
Results First Submitted: August 7, 2013
Results First Posted: October 14, 2013
Last Update Posted: November 26, 2013