Schizophrenia | Risperidone and Desipramine in Alcohol Use and Schizophrenia
Schizophrenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Meets the diagnostic criteria of schizophrenia or schizoaffective disorder 2. Meets the diagnostic criteria for a current alcohol use disorder (abuse or dependence) 3. Recent alcohol use as documented on the Timeline Followback 4. Receives outpatient treatment with oral antipsychotic medication (including risperidone. 5. Is willing to switch to risperidone treatment at the beginning of the study. Exclusion Criteria: 1. Other substance use disorder other than alcohol, caffeine and nicotine, and cannabis abuse, as defined by DSM-IV criteria. 2. Receives current treatment with Clozapine 3. Continues to use alcohol despite current adequate treatment with medication to decrease alcohol use(e.g. naltrexone, acamprosate, disulfiram or topiramate) 4. Is determined to be a \"slow metabolizer\" of CYP2D6 5. Is currently pregnant, trying to become pregnant, or nursing
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Risperidone + Desipramine
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Risperidone + DesipramineAll participants will be treated with risperidone (or a risperidone-like agent including: risperidone long-acting, paliperdione, and paliperidone palmitate) at the time treatment with desipramine is initiated. The target dose of oral risperidone is 4mg though variations are allowed. The target dose of desipramine is 100mg.
Start Date: December 2011
Completed Date: September 2014
Phase: Phase 2
Primary Outcome: Timeline Followback Assessing Number of Drinks Per Week
Study sponsors, principal investigator, and references
Principal Investigator: Alan I Green, MD
Lead Sponsor: Dartmouth-Hitchcock Medical Center
Collaborator: University of South Carolina