A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT00391222
First received: October 20, 2006
Last updated: May 19, 2011
Last verified: May 2011
Results First Received: April 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: Risperidone Long Acting Injectable (LAI)
Drug: Olanzapine
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
This study was run from 14 November 2006 to 13 April 2009. Patients were recruited at 70 investigational sites located in 14 countries across Europe, Asia, Latin-America, and Africa.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were treated appropriately or continued previous treatment. At baseline, treatment with Risperidone Long Acting Injectable (LAI) was started. During 12 weeks patients were stabilized on risperidone LAI and treatment with antipsychotics, mood stabilizers and other psychotropics was titrated off unless otherwise specified in the protocol.

Reporting Groups
  Description
Risperidone LAI Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
Placebo Double-blind Period III: placebo injections every 14 days and oral placebo daily
Olanzapine Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
Open-label Risperidone LAI Open-label Period II: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days

Participant Flow for 2 periods

Period 1:   Period II (Open-label Risperidone LAI)
    Risperidone LAI     Placebo     Olanzapine     Open-label Risperidone LAI  
STARTED     0     0     0     560 [1]
COMPLETED     0     0     0     398  
NOT COMPLETED     0     0     0     162  
Withdrawal by Subject                 0                 0                 0                 26  
Lost to Follow-up                 0                 0                 0                 5  
Adverse Event                 0                 0                 0                 10  
Non-responder                 0                 0                 0                 97  
Unknown                 0                 0                 0                 24  
[1] The 25 patients at the site of Dr. Parikh were excluded from the analysis due to GCP non-compliance

Period 2:   Period III (Double-Blind Treatment)
    Risperidone LAI     Placebo     Olanzapine     Open-label Risperidone LAI  
STARTED     132 [1]   135 [1]   131 [1]   0  
COMPLETED     104     113     108     0  
NOT COMPLETED     28     22     23     0  
Withdrawal by Subject                 15                 12                 6                 0  
Lost to Follow-up                 2                 4                 4                 0  
Adverse Event                 5                 2                 4                 0  
Pregnancy                 0                 2                 0                 0  
Study Medication Non-compliant                 0                 1                 3                 0  
Unknown                 6                 1                 6                 0  
[1] Patients were randomized to one of 3 arms in Period III, after completing open-label Period II



  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.
No text entered.

Reporting Groups
  Description
Risperidone LAI Double-blind Period III: risperidone long-acting injectable intramuscular every 14 days and oral placebo daily
Placebo Double-blind Period III: placebo injections every 14 days and oral placebo daily
Olanzapine Double-blind Period III: placebo injections every 14 days and oral olanzapine 10 mg/day
Total Total of all reporting groups

Baseline Measures
    Risperidone LAI     Placebo     Olanzapine     Total  
Number of Participants  
[units: participants]
  132     135     131     398  
Age  
[units: years]
Mean ± Standard Deviation
  35.76  ± 11.23     36.87  ± 11.08     36.57  ± 11.10     36.41  ± 11.12  
Gender  
[units: participants]
       
Female     78     71     59     208  
Male     54     64     72     190  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo)   [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

2.  Secondary:   Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode   [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

3.  Secondary:   Time to Recurrence of a Depressive Episode   [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

4.  Secondary:   Time to Early Study Discontinuation for Any Reason   [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

5.  Secondary:   Change From Double-blind Baseline to Endpoint in Young Mania Rating Scale (YMRS)   [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

6.  Secondary:   Change From Double-blind Baseline to Endpoint in Montgomery Åsberg Depression Rating Scale (MADRS)   [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]

7.  Secondary:   Time to Recurrence of a Mood Episode (Exploratory/Olanzapine)   [ Time Frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) ]


  Serious Adverse Events


  Other Adverse Events


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: EMEA Medical Affairs Director
Organization: Janssen Cilag Spain
phone: +34 91 7228043


No publications provided


Responsible Party: EMEA Medical Affairs Director, Janssen-Cilag S.A., Spain
ClinicalTrials.gov Identifier: NCT00391222     History of Changes
Obsolete Identifiers: NCT01205113
Other Study ID Numbers: CR012145
Study First Received: October 20, 2006
Results First Received: April 19, 2010
Last Updated: May 19, 2011
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment