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Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

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: NCT00852202
Recruitment Status : Completed
First Posted : February 26, 2009
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bipolar Depression
Interventions Drug: cariprazine
Drug: placebo
Enrollment 234
Recruitment Details  
Pre-assignment Details 233 patients were randomized to receive double-blind treatment, 227 patients received at least 1 dose of double-blind treatment and were included in safety Population
Arm/Group Title Placebo 0.25 to 0.75 mg Cariprazine 1.5 to 3.0 mg Cariprazine
Hide Arm/Group Description Matching placebo capsules, orally administered for 8 weeks Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks 1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks
Period Title: Overall Study
Started 77 75 75
Completed 60 63 49
Not Completed 17 12 26
Reason Not Completed
Adverse Event             2             3             7
Lack of Efficacy             4             1             2
Protocol Violation             2             2             7
Withdrawal by Subject             3             1             2
Lost to Follow-up             5             5             6
pregnancy,moving away and surgery             1             0             2
Arm/Group Title Placebo 0.25 to 0.75 mg Cariprazine 1.5 to 3.0 mg Cariprazine Total
Hide Arm/Group Description Matching placebo capsules, orally administered for 8 weeks Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks Cariprazine capsules 1.5 to 3.0 mg was orally administrated once daily for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 77 75 75 227
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 75 participants 75 participants 227 participants
40.6  (10.7) 37.4  (10.7) 38.8  (12.1) 38.9  (11.2)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 75 participants 75 participants 227 participants
< 20 1 1 2 4
20, 30 11 21 18 50
30, 40 24 20 20 64
40, 50 23 23 20 66
50, 60 17 10 13 40
≥ 60 1 0 2 3
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 77 participants 75 participants 75 participants 227 participants
Female 46 48 51 145
Male 31 27 24 82
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 75 participants 75 participants 227 participants
Hispanic or Latino
3
   3.9%
4
   5.3%
6
   8.0%
13
   5.7%
Not Hispanic or Latino
74
  96.1%
71
  94.7%
69
  92.0%
214
  94.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 75 participants 75 participants 227 participants
Caucasian 54 56 62 172
Non-Caucasian 23 19 13 55
Black 19 16 11 46
Asian 2 2 1 5
Other 2 1 1 4
American Indian or Alaska Native 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0 0
1.Primary Outcome
Title Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 54 for 1.5 to 3.0 mg Cariprazine
Arm/Group Title Placebo 0.25 to 0.75 mg Cariprazine 1.5 to 3.0 mg Cariprazine
Hide Arm/Group Description:
Matching placebo capsules, orally administered for 8 weeks
Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
Cariprazine capsules 1.5 to 3.0 mg was orally administrated once daily for 8 weeks
Overall Number of Participants Analyzed 60 64 54
Mean (Standard Error)
Unit of Measure: Score on scale
29.9  (0.6) 30.2  (0.6) 30.9  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 0.25 to 0.75 mg Cariprazine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7408
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 1.5 to 3.0 mg Cariprazine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9961
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Baseline in Clinical Global Impressions–Improvement ( CGI-I )
Hide Description The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 53 for 1.5 to 3.0 mg Cariprazine
Arm/Group Title Placebo 0.25 to 0.75 mg Cariprazine 1.5 to 3.0mg Cariprazine
Hide Arm/Group Description:
Matching placebo capsules, orally administered for 8 weeks
Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
Cariprazine capsules 1.5 to 3.0 mg was orally administrated once daily for 8 weeks
Overall Number of Participants Analyzed 60 64 74
Mean (Standard Error)
Unit of Measure: Score on Scale
2.1  (0.1) 2.1  (0.1) 2.1  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 0.25 to 0.75 mg Cariprazine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3441
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 1.5 to 3.0mg Cariprazine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2683
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 0.25 to 0.75 mg Cariprazine 1.5 to 3.0 mg Cariprazine
Hide Arm/Group Description Matching placebo capsules, orally administered for 8 weeks Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks 1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks
All-Cause Mortality
Placebo 0.25 to 0.75 mg Cariprazine 1.5 to 3.0 mg Cariprazine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 0.25 to 0.75 mg Cariprazine 1.5 to 3.0 mg Cariprazine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/77 (2.60%)   2/75 (2.67%)   2/75 (2.67%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/77 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Psychiatric disorders       
Bipolar I disorder  1  0/77 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
Suicidal ideation  1  1/77 (1.30%)  0/75 (0.00%)  1/75 (1.33%) 
Suicidal attempt  1  0/77 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Bipolar disorder  1  1/77 (1.30%)  0/75 (0.00%)  0/75 (0.00%) 
Depression  1  0/77 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA version 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 0.25 to 0.75 mg Cariprazine 1.5 to 3.0 mg Cariprazine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/77 (66.23%)   48/75 (64.00%)   52/75 (69.33%) 
Gastrointestinal disorders       
Nausea  1  4/77 (5.19%)  9/75 (12.00%)  9/75 (12.00%) 
Diarrhoea  1  5/77 (6.49%)  10/75 (13.33%)  5/75 (6.67%) 
Vomiting  1  1/77 (1.30%)  1/75 (1.33%)  5/75 (6.67%) 
Dry mouth  1  4/77 (5.19%)  7/75 (9.33%)  10/75 (13.33%) 
Constipation  1  5/77 (6.49%)  5/75 (6.67%)  3/75 (4.00%) 
Flatulence  1  4/77 (5.19%)  1/75 (1.33%)  0/75 (0.00%) 
General disorders       
Fatigue  1  5/77 (6.49%)  7/75 (9.33%)  6/75 (8.00%) 
Infections and infestations       
Nasopharyngitis  1  5/77 (6.49%)  7/75 (9.33%)  7/75 (9.33%) 
Upper respiratory tract infection  1  8/77 (10.39%)  11/75 (14.67%)  8/75 (10.67%) 
Investigations       
Weight Increase  1  1/77 (1.30%)  1/75 (1.33%)  6/75 (8.00%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal stiffness  1  0/77 (0.00%)  0/75 (0.00%)  4/75 (5.33%) 
Nervous system disorders       
Akathisia  1  5/77 (6.49%)  2/75 (2.67%)  13/75 (17.33%) 
Headache  1  12/77 (15.58%)  11/75 (14.67%)  12/75 (16.00%) 
Migraine  1  1/77 (1.30%)  5/75 (6.67%)  0/75 (0.00%) 
Dizziness  1  5/77 (6.49%)  2/75 (2.67%)  3/75 (4.00%) 
Dysgeusia  1  4/77 (5.19%)  1/75 (1.33%)  2/75 (2.67%) 
Sedation  1  5/77 (6.49%)  2/75 (2.67%)  1/75 (1.33%) 
Psychiatric disorders       
Insomnia  1  7/77 (9.09%)  13/75 (17.33%)  15/75 (20.00%) 
Anxiety  1  5/77 (6.49%)  2/75 (2.67%)  5/75 (6.67%) 
Restlessness  1  3/77 (3.90%)  2/75 (2.67%)  5/75 (6.67%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/77 (1.30%)  4/75 (5.33%)  0/75 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA version 13.0
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.
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan Sales LLC
Phone: 877-277-8566
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00852202     History of Changes
Other Study ID Numbers: RGH-MD-52
First Submitted: February 25, 2009
First Posted: February 26, 2009
Results First Submitted: June 25, 2018
Results First Posted: August 23, 2018
Last Update Posted: August 23, 2018