CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 95 enrolled
Drug / intervention
Risperidone Long Acting +1 moredrug
Likely dose
Risperidone long-acting 25–50 mg intramuscularly every 2 weeks, or oral risperidone 0.5–6 mg dailyAI-extracted
Key inclusion· 5
  • ✓Age 18–65 years
  • ✓Diagnosed schizophrenia or schizoaffective disorder
  • ✓Meets DSM-IV criteria for alcohol use disorder by structured interview
  • ✓Alcohol use on ≥5 days in the 4 weeks prior to randomization
Key exclusion· 7
  • ✕Current clozapine use
  • ✕Current injectable risperidone long-acting
  • ✕Pregnancy, planning pregnancy, or unwilling to use contraception
  • ✕Medication change in past 30 days (dose adjustment, discontinuation, or new medication)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00130923
NCT00130923Phase 4Completed
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Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)

Dartmouth-Hitchcock Medical Center·interventional·Posted Aug 16, 2005·Updated May 9, 2019

In Brief

A Phase 4 clinical trial evaluating Risperidone Long Acting and oral risperidone for Schizophrenia and 3 related conditions. Completed, enrolled 95 participants across 8 sites.

Detailed Summary

The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Psychotic Disorders, Substance Abuse, Alcohol Abuse
CountriesUnited States
CollaboratorsJanssen, LP

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2005
Enrollment StartSep 1, 2005
Primary CompletionJun 1, 2009
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.9 years ago

Interventions

Risperidone Long Actingdrug

Dose 25.00, 37.50 or 50.00 mg q two weeks

oral risperidonedrug

0.50-6.00 mg oral risperidone daily