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Risperdal Consta for Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
K.N. Roy Chengappa, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177164
First received: September 12, 2005
Last updated: March 17, 2016
Last verified: March 2016
Results First Received: January 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bipolar I Disorder
Intervention: Drug: Injectable Risperidone (Consta) or oral antipsychotic

  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
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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
Risperidone LAI

Oral Risperidone followed by Long acting Risperidone injections (Consta)

Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks

Oral AAP

Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)

Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder


Participant Flow:   Overall Study
    Risperidone LAI   Oral AAP
STARTED   23   25 
COMPLETED   14   9 
NOT COMPLETED   9   16 
Protocol Violation                0                7 
Lost to Follow-up                4                5 
increase in alcohol and drug use                1                2 
Adverse Event                1                0 
discharge from hospital                1                0 
Lack of Efficacy                2                1 
Pregnancy                0                1 



  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.
Two patients in the Risperidone LAI group were not included in the analysis as they did not receive any assessment after the baseline assessment

Reporting Groups
  Description
Risperidone LAI

Oral Risperidone followed by Long acting Risperidone injections (Consta)

Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks

Oral AAP

Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)

Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder

Total Total of all reporting groups

Baseline Measures
   Risperidone LAI   Oral AAP   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   25   48 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   23   25   48 
>=65 years   0   0   0 
Gender [1] 
[Units: Participants]
     
Female   16   18   34 
Male   7   7   14 
[1] 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Race (NIH/OMB) [1] 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   6   3   9 
White   16   22   38 
More than one race   0   0   0 
Unknown or Not Reported   1   0   1 
[1] 2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.
Region of Enrollment 
[Units: Participants]
     
United States   23   25   48 


  Outcome Measures
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1.  Primary:   Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.   [ Time Frame: Upto 15 months ]

2.  Secondary:   BMI   [ Time Frame: baseline to end of 15 months ]

3.  Secondary:   Number of Participants With Treatment - Emergent Hyperglycemia   [ Time Frame: from baseline to end of 15 months ]

4.  Secondary:   Number of Participants With Treatment Emergent Hyperlipidemia   [ Time Frame: from baseline to end of 15 months ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: K.N. Roy Chengappa
Organization: UPMC
phone: 412-246-5006
e-mail: chengappakn@upmc.edu


Publications of Results:

Responsible Party: K.N. Roy Chengappa, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177164     History of Changes
Other Study ID Numbers: RIS-PSY-405
Univ. Pittsburgh IRB #0403091
Study First Received: September 12, 2005
Results First Received: January 7, 2016
Last Updated: March 17, 2016
Health Authority: United States: Food and Drug Administration