Risperidone and Desipramine in Alcohol Use and Schizophrenia
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
Note: In June 2013, the study design was changed from a randomized controlled study of
risperidone + despiramine vs. risperidone vs. placebo to an open label pre-post study of
risperidone (or risperidone-like drug) + desipramine. The aims of the study were revised to
read:
1. To determine whether participants treated with risperidone in combination with
desiprmaine have less alcohol use (fewer drinking days; fewer heavy drinking days)
during the final 8 weeks on these medications as compared to pre-baseline. The primary
hypothesis is that compared to pre-baseline, participants will demonstrate fewer days of
drinking (per week), as well as fewer days of heavy drinking (per week) in the final
eight weeks they are taking risperidone and desipramine, as recorded on the Timeline
Follow-Back assessment
2. To explore changes in symptoms (of schizophrenia and of depression) in the final eight
weeks of treatment with risperidone + desipramine compared to the period before baseline
3. To assess the side effect burden associated with the combination of these two
medications in participants.
The original aims of the study were:
The purpose of this study is to determine whether participants who are treated with
risperidone in combination with desipramine have less alcohol use (fewer drinking days; fewer
heavy drinking days) than do participants who are treated with RISP with placebo. The primary
hypothesis is that compared to treatment with risperidone, participants randomized to a
combination of risperidone plus desipramine will have fewer days of drinking, as well as
fewer days of heavy drinking. The study will also compare the effects of risperidone as
compared to risperidone plus desipramine on participants' symptoms and side effects.
Phase:
Phase 2
Details
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborators:
Michigan State University University of Massachusetts, Worcester University of South Carolina