Status:
COMPLETED
Risperidone and Desipramine in Alcohol Use and Schizophrenia
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
University of South Carolina
University of Massachusetts, Worcester
Conditions:
Schizophrenia
Alcoholism
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 risperid...
Detailed Description
Alcohol use disorder is at least three times more common in schizophrenia than in the general population, and worsens the course of schizophrenia. Typical antipsychotic agents are of limited value in ...
Eligibility Criteria
Inclusion
- Meets the diagnostic criteria of schizophrenia or schizoaffective disorder
- Meets the diagnostic criteria for a current alcohol use disorder (abuse or dependence)
- Recent alcohol use as documented on the Timeline Followback
- Receives outpatient treatment with oral antipsychotic medication (including risperidone.
- Is willing to switch to risperidone treatment at the beginning of the study.
Exclusion
- Other substance use disorder other than alcohol, caffeine and nicotine, and cannabis abuse, as defined by DSM-IV criteria.
- Receives current treatment with Clozapine
- Continues to use alcohol despite current adequate treatment with medication to decrease alcohol use(e.g. naltrexone, acamprosate, disulfiram or topiramate)
- Is determined to be a "slow metabolizer" of CYP2D6
- Is currently pregnant, trying to become pregnant, or nursing
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01411085
Start Date
December 1 2011
End Date
September 1 2014
Last Update
March 23 2018
Active Locations (4)
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1
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605
2
Michigan State University / Cherry Street Health Services
Grand Rapids, Michigan, United States, 49503
3
Dartmouth Medical School
Lebanon, New Hampshire, United States, 03756
4
University of South Carolina School of Medicine
Columbia, South Carolina, United States, 29203