Long-Acting Injectable Risperidone in the Treatment of Schizophrenia

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. Identifier: NCT00132314
Recruitment Status : Completed
First Posted : August 19, 2005
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Schizoaffective Disorder
Interventions: Drug: IM risperidone
Drug: oral antipsychotic medication

  Participant Flow

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
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

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

Baseline Measures
   Injectable Risperidone   Oral Antipsychotic   Total 
Overall Participants Analyzed 
[Units: Participants]
 187   182   369 
[Units: Years]
Mean (Standard Deviation)
 50.6  (9.7)   51.3  (8.8)   50.9  (9.3) 
[Units: Participants]
Female   15   17   32 
Male   172   165   337 

  Outcome Measures

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

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.

  More Information

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: VA Office of Research and Development Identifier: NCT00132314     History of Changes
Other Study ID Numbers: 555
First Submitted: August 17, 2005
First Posted: August 19, 2005
Results First Submitted: May 29, 2013
Results First Posted: December 20, 2013
Last Update Posted: December 20, 2013