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Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00488618
First Posted: June 20, 2007
Last Update Posted: April 14, 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
Condition: Bipolar Disorder
Interventions: Drug: Cariprazine (RGH-188)
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
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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:   Overall Study
    Placebo   Cariprazine
STARTED   120   118 
Safety Population: Received Study Drug   118   118 
COMPLETED   73   75 
NOT COMPLETED   47   43 
Adverse Event                13                17 
Insufficient Therapeutic Response                18                11 
Protocol Violation                0                2 
Withdrawal of Consent                15                13 
Lost to Follow-up                1                0 



  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 participants who received at least 1 dose of study drug.

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]
 118   118   236 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.7  (11.0)   38.0  (10.3)   38.3  (10.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      41  34.7%      38  32.2%      79  33.5% 
Male      77  65.3%      80  67.8%      157  66.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      4   3.4%      6   5.1%      10   4.2% 
Not Hispanic or Latino      114  96.6%      112  94.9%      226  95.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Caucasian   55   47   102 
Black   31   36   67 
Asian   28   30   58 
Other   4   5   9 
Weight 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 79.3  (20.0)   75.0  (20.3)   77.2  (20.2) 
Height 
[Units: Centimeter (cm)]
Mean (Standard Deviation)
 170.0  (10.4)   169.9  (10.0)   170.0  (10.2) 
Body Mass Index (BMI) 
[Units: Kg/meter(m)^2]
Mean (Standard Deviation)
 27.2  (5.8)   25.8  (5.9)   26.5  (5.9) 


  Outcome Measures
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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, 3 Weeks ]


  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
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  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: NCT00488618     History of Changes
Other Study ID Numbers: RGH-MD-31
First Submitted: June 19, 2007
First Posted: June 20, 2007
Results First Submitted: March 1, 2017
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017