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Clinical trialNCT00132314CompletedPhase 3Interventional

Long-Acting Injectable Risperidone in the Treatment of Schizophrenia

SponsorUS Department of Veterans AffairsEnrollment382Schizoaffective DisorderSchizophrenia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Va Medical Center, Tuscaloosa

    Tuscaloosa, Alabama, United States

  • Va Medical Center, Long Beach

    Long Beach, California, United States

  • Va Palo Alto Health Care System

    Palo Alto, California, United States

  • Va Connecticut Health Care System (west Haven)

    West Haven, Connecticut, United States

  • Va Medical Center, Miami

    Miami, Florida, United States

  • Va Medical Center, Augusta

    Augusta, Georgia, United States

  • Jesse Brown Vamc (westside Division)

    Chicago, Illinois, United States

  • Va Medical Center, Jamaica Plain Campus

    Boston, Massachusetts, United States

  • John D. Dingell Va Medical Center, Detroit

    Detroit, Michigan, United States

  • Va Medical Center, Minneapolis

    Minneapolis, Minnesota, United States

  • Va Medical Center, Kansas City Mo

    Kansas City, Missouri, United States

  • Va Medical Center, Omaha

    Omaha, Nebraska, United States

  • New Mexico Va Health Care System, Albuquerque

    Albuquerque, New Mexico, United States

  • New York Harbor Hcs

    New York, New York, United States

  • Va Medical Center, Cleveland

    Cleveland, Ohio, United States

  • Va Medical Center, Philadelphia

    Philadelphia, Pennsylvania, United States

  • Michael E. Debakey Va Medical Center (152)

    Houston, Texas, United States

  • Central Texas Veterans Health Care System - Waco

    Waco, Texas, United States

  • Va Puget Sound Health Care System, Seattle

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

IM risperidoneOral antipsychotic medication
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2006
Primary completion
30 Sept 2009
Completion
30 Sept 2009
Last update posted
20 Dec 2013
Registered enrollment
382
Registry id
NCT00132314

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.