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Safety and Efficacy of Cariprazine for Mania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01058096
First Posted: January 28, 2010
Last Update Posted: April 17, 2017
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.
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
Results First Submitted: March 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Mania
Interventions: Drug: Cariprazine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
11 participants from 1 investigational site are not included in the analyses due to Good Clinical Practice (GCP) violations.

Reporting Groups
  Description
Placebo Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Cariprazine Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.

Participant Flow for 2 periods

Period 1:   Double-blind Treatment Phase
    Placebo   Cariprazine
STARTED   154   158 
COMPLETED   106   108 
NOT COMPLETED   48   50 
Adverse Event                11                15 
Insufficient Therapeutic Response                16                7 
Protocol Violation                2                1 
Withdrawal of Consent                17                26 
Lost to Follow-up                0                1 
Other Unspecified                2                0 

Period 2:   Safety Follow-up
    Placebo   Cariprazine
STARTED   133 [1]   134 
COMPLETED   129   130 
NOT COMPLETED   4   4 
[1] Not all participants continued to Safety Follow-up.



  Baseline Characteristics
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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 included all randomized participants who took at least 1 dose of double-blind investigational product.

Reporting Groups
  Description
Placebo Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Cariprazine Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Cariprazine   Total 
Overall Participants Analyzed 
[Units: Participants]
 154   158   312 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.7  (11.8)   35.8  (11.4)   36.3  (11.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      59  38.3%      53  33.5%      112  35.9% 
Male      95  61.7%      105  66.5%      200  64.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      5   3.2%      5   3.2%      10   3.2% 
Not Hispanic or Latino      149  96.8%      153  96.8%      302  96.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   33   33   66 
Black/African American   29   33   62 
Asian   88   91   179 
American Indian or Alaska Native   3   0   3 
Other   1   1   2 
Weight 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 71.86  (20.27)   69.55  (20.06)   70.69  (20.17) 
Height 
[Units: Centimeter (cm)]
Mean (Standard Deviation)
 166.39  (10.64)   165.21  (10.68)   165.79  (10.66) 
Body Mass Index (BMI) 
[Units: Kg/meter(m)^2]
Mean (Standard Deviation)
 25.73  (5.98)   25.24  (5.98)   25.48  (5.98) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3   [ Time Frame: Baseline, Week 3 ]

2.  Secondary:   Change From Baseline in Clinical Global Impression–Severity (CGI-S) Total Score at Week 3   [ Time Frame: Baseline, Week 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
All participants from 1 investigative site are excluded due to GCP violations.


  More Information
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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, Inc.
phone: 714-246-4500



Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01058096     History of Changes
Other Study ID Numbers: RGH-MD-32
First Submitted: January 27, 2010
First Posted: January 28, 2010
Results First Submitted: March 1, 2017
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017