Risperidone and Desipramine in Alcohol Use and Schizophrenia

NCT01411085 | Completed Phase 2 Results DMC

• 1 other identifier: 1R21AA019534-01A1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

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 risperidone-like drug) + desipramine. The aims of the study were revised to read:

1. 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. 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. 3.To assess the side effect burden associated with the combination of these two medications in participants.

Conditions

Schizophrenia; Alcoholism; Dual Diagnosis

Keywords

Schizophrenia; Alcoholism; Dual Diagnosis; Desipramine; Risperidone

Outcome Measures

Primary Outcomes (1)

• Timeline Followback Assessing Number of Drinks Per Week

  Alcohol/other substance use (including tobacco) will be assessed primarily by weekly self-report using the Timeline Followback (TLFB) method enhanced by procedures to strengthen the reliability and validity of this measure. It involves asking participants to retrospectively estimate their alcohol and other substance use.

  Weekly for 14 weeks, using data from last 8 weeks

Study Arms (1)

Risperidone + Desipramine

EXPERIMENTAL

All 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.

Drug: Risperidone + Desipramine

Interventions

Risperidone + Desipramine DRUG

Also known as: Norpramin

Risperidone + Desipramine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• University of South Carolina: collaborator
• University of Massachusetts, Worcester: collaborator
• Michigan State University: collaborator

Study Sites (4)

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

Michigan State University / Cherry Street Health Services

Grand Rapids, Michigan, 49503, United States

Location

Dartmouth Medical School

Lebanon, New Hampshire, 03756, United States

Location

University of South Carolina School of Medicine

Columbia, South Carolina, 29203, United States

Location

MeSH Terms

Conditions

Schizophrenia; Alcoholism

Interventions

Risperidone; Desipramine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Alan I Green, MD
• Organization: Geisel School of Medicine at Dartmouth

alan.i.green@dartmouth.edu

603-650-7549

Study Officials

• Alan I Green, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: August 8, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 23, 2018
• Results First Posted: March 23, 2018

Record last verified: 2018-03

Locations

US (4)