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Long-Acting Injectable Risperidone in the Treatment of Schizophrenia

NCT00132314 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2013-12-20

Study results available
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Summary

In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but not specifying any particular oral agents or dosages). Recruitment would take 27 months to complete, and the study would continue for a third year to allow 9 months of follow-up for the last patient recruited. All patients would be treated from the time of entry up to the end of the three-year study period. Follow-up assessments would continue quarterly. Treatments would not be blinded since giving placebo injections to the comparison group would interfere with the goal of comparing the acceptability of two different methods of medication administration. However, end points will be blindly rated.

Conditions

Interventions

DRUG

IM risperidone

long-acting injectable risperidone

DRUG

oral antipsychotic medication

doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)

Sponsors & Collaborators

Principal Investigators

  • Robert A. Rosenheck, AB MD · VA Connecticut Health Care System (West Haven)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00132314 on ClinicalTrials.gov