Last reviewed · How we verify
Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)
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.
Details
| Lead sponsor | Dartmouth-Hitchcock Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 95 |
| Start date | 2005-09 |
| Completion | 2010-07 |
Conditions
- Schizophrenia
- Psychotic Disorders
- Substance Abuse
- Alcohol Abuse
Interventions
- Risperidone Long Acting
- oral risperidone
Primary outcomes
- Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy) — 6 months
Frequency of heavy drinking days is obtained each week retrospectively as the number of heavy drinking days during the prior week (assessed by the Timeline Followback Scale). A heavy drinking day is defined as 4 or more drinks per day for a female and 5 or more drinks per day for a male. Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.
Countries
United States