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Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01396447
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : May 1, 2018
Last Update Posted : May 1, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression, Bipolar
Interventions: Drug: Placebo
Drug: Cariprazine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult participants with a diagnosis of bipolar I disorder with a current major depressive episode were considered for participation in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo orally once a day for 8 weeks.
Cariprazine 0.75 mg Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
Cariprazine 1.5 mg Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
Cariprazine 3.0 mg Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.

Participant Flow:   Overall Study
    Placebo   Cariprazine 0.75 mg   Cariprazine 1.5 mg   Cariprazine 3.0 mg
STARTED   148   143   147   146 
Received Treatment   145   141   146   146 
COMPLETED   105   103   117   94 
NOT COMPLETED   43   40   30   52 
Did Not Receive Treatment                3                2                1                0 
Adverse Event                15                12                12                17 
Insufficient Therapeutic Response                5                5                2                4 
Protocol Violation                5                2                3                7 
Withdrawal of Consent                11                9                4                15 
Lost to Follow-up                4                8                7                9 
Other Miscellaneous Reasons                0                2                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population: All randomized participants who received at least 1 dose of investigational product.

Reporting Groups
  Description
Placebo Participants received placebo orally once a day for 8 weeks.
Cariprazine 0.75 mg Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
Cariprazine 1.5 mg Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
Cariprazine 3.0 mg Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Total Total of all reporting groups

Baseline Measures
   Placebo   Cariprazine 0.75 mg   Cariprazine 1.5 mg   Cariprazine 3.0 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 145   141   146   146   578 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.6  (12.0)   40.1  (11.2)   40.9  (11.4)   42.8  (10.8)   41.9  (11.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      89  61.4%      91  64.5%      92  63.0%      88  60.3%      360  62.3% 
Male      56  38.6%      50  35.5%      54  37.0%      58  39.7%      218  37.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      12   8.3%      13   9.2%      11   7.5%      12   8.2%      48   8.3% 
Not Hispanic or Latino      133  91.7%      128  90.8%      135  92.5%      134  91.8%      530  91.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
White      110  75.9%      111  78.7%      109  74.7%      113  77.4%      443  76.6% 
Black or African-American      30  20.7%      26  18.4%      30  20.5%      26  17.8%      112  19.4% 
Asian      1   0.7%      1   0.7%      2   1.4%      0   0.0%      4   0.7% 
American Indian or Alaska Native      2   1.4%      1   0.7%      1   0.7%      3   2.1%      7   1.2% 
Other      2   1.4%      2   1.4%      4   2.7%      4   2.7%      12   2.1% 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 79.98  (17.08)   80.81  (18.36)   81.43  (16.79)   81.45  (17.86)   80.92  (17.49) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 27.81  (5.27)   28.42  (5.71)   28.44  (5.39)   28.28  (5.64)   28.24  (5.50) 
Waist circumference 
[Units: Cm]
Mean (Standard Deviation)
 91.40  (14.24)   93.32  (15.45)   93.38  (14.55)   93.24  (15.40)   92.83  (14.90) 


  Outcome Measures

1.  Primary:   Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6   [ Time Frame: Baseline to Week 6 ]

2.  Secondary:   Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6   [ Time Frame: Baseline to Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Allergan
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01396447     History of Changes
Other Study ID Numbers: RGH-MD-56
2011-002334-39 ( EudraCT Number )
First Submitted: July 15, 2011
First Posted: July 18, 2011
Results First Submitted: March 29, 2018
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018