Clozapine and Antipsychotic Agents and Clozapine versus typical (conventional) and atypical antipsychotic medications in Schizophrenia and Schizoaffective Disorder and Substance Abuse - Clinical Trials Registry

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Drug: Clozapine versus typical (conventional) and atypical antipsychotic medications

Study Type

Interventional

Enrollment

64

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Jamaica Plain, Massachusetts, United States, 02130
    - Commonwealth Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder
Current diagnosis of an alcohol use disorder with active use in the last 30 days.
The participant (or the participant's authorized legal representative) understands the nature of the study and has he/she signed an informed consent.
Ages 19-65.
Taking olanzapine, risperidone, quetiapine or a typical antipsychotic agent for at least 8 weeks prior to study randomization
If taking depot medication, at least 3 injection cycles since the last injection prior to study randomization.

Exclusion Criteria:

Contraindication to clozapine
Women who are currently pregnant or who desire to become pregnant during the course of the study.
Current and past treatment with clozapine
Current treatment with agents proposed to curtail substance use (e.g., disulfiram, naltrexone, acamprosate, buspirone) and agents contraindicated for use with clozapine (e.g., inderal, tegretol, lithium).
Meets DSM-IV criteria for current dependence of substances other than alcohol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Self report using the weekly Time Line Follow Back; Alcohol Use Scale and Drug Use Scale obtained by clinician and key informant; breathalyzer and urine drug screen. Monthly consensus in substance use rating; monthly CDT and clozapine blood levels.

Secondary Outcome Measures

Outcome Measure
Clinical Measures: Brief Psychiatric Rating Scale; Scale for the Assessment of Negative Symptoms; and Clinical Global Impression; neurological side affects, cognitive assessment and quality of life measure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Harvard Medical School (HMS and HSDM)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Novartis

Commonwealth Research Center, Massachusetts

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Green AI, Zimmet SV, Strous RD, Schildkraut JJ. Clozapine for comorbid substance use disorder and schizophrenia: do patients with schizophrenia have a reward-deficiency syndrome that can be ameliorated by clozapine? Harv Rev Psychiatry. 1999 Mar-Apr;6(6):287-96. doi: 10.3109/10673229909017206.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Study Completion

January 1, 2004

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria