Long-Acting Injectable Risperidone in the Treatment of Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00132314
First received: August 17, 2005
Last updated: October 30, 2013
Last verified: October 2013
Results First Received: May 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizoaffective Disorder
Schizophrenia
Interventions: Drug: IM risperidone
Drug: oral antipsychotic medication

  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
September 2006 - December 2008; 19 VA medical centers

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
Injectable Risperidone long-acting injectable risperidone
Oral Antipsychotic oral antipsychotic medication

Participant Flow:   Overall Study
    Injectable Risperidone     Oral Antipsychotic  
STARTED     190     192  
Received Treatment     188     185  
Completed Baseline Visit, Provided SSN     187 [1]   182 [2]
COMPLETED     117     120  
NOT COMPLETED     73     72  
Lost to Follow-up                 70                 62  
Lacked SSN                 1                 3  
Refused intervention at baseline                 2                 7  
[1] This is the ITT cohort
[2] This is the ITT cohort.



  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.
We used the intention to treat (ITT) population as defined in Milestone 2.

Reporting Groups
  Description
Injectable Risperidone long-acting injectable risperidone
Oral Antipsychotic oral antipsychotic medication
Total Total of all reporting groups

Baseline Measures
    Injectable Risperidone     Oral Antipsychotic     Total  
Number of Participants  
[units: participants]
  187     182     369  
Age  
[units: years]
Mean ± Standard Deviation
  50.6  ± 9.7     51.3  ± 8.8     50.9  ± 9.3  
Gender  
[units: participants]
     
Female     15     17     32  
Male     172     165     337  



  Outcome Measures
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1.  Primary:   Hospitalization-free Survival - Time to Event   [ Time Frame: From randomization until date of first re-hospitalization, assessed up to 24 months ]

2.  Primary:   Hazard Ratio for Hospitalization   [ Time Frame: 24 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert Rosenheck, MD
Organization: VA New England Mental Illness, Research, Education and Clinical Center
phone: (203) 932-5711 ext 3723
e-mail: Robert.Rosenheck@va.gov


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00132314     History of Changes
Other Study ID Numbers: 555
Study First Received: August 17, 2005
Results First Received: May 29, 2013
Last Updated: October 30, 2013
Health Authority: United States: Federal Government