Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder

NCT03857581 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 1303985
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to determine if patients with comorbid psychotic disorder and substance use disorder will continue in treatment longer if treated with clozapine than with olanzapine, and will have greater reductions in psychosis and in substance use if treated with clozapine than treated with olanzapine. The specific aims and hypotheses of this trial are: 1. To compare the enduring effectiveness and tolerability of clozapine and olanzapine, as measured by time to all-cause treatment discontinuation, over 12 weeks of follow-up; The investigators hypothesize that patients assigned to clozapine treatment will have significantly longer times to all cause treatment discontinuation, 2. To compare the total psychosis items scores between patients treated with clozapine and patients treated with olanzapine over 12 weeks of follow-up; The investigators hypothesize that patients treated with clozapine will have significantly lower total psychosis items scores than patients treated with olanzapine, and 3. To compare the frequencies of positive urine drug screens and blood alcohol levels (obtained weekly throughout 12 weeks of follow-up) between patients treated with clozapine and patients treated with olanzapine; The investigators hypothesize that patients treated with clozapine will have significantly fewer positive urine drug screens and blood alcohol levels than patients treated with olanzapine.

Conditions

Psychosis; Substance Use Disorders

Keywords

Schizophrenia; Schizoaffective disorder; Bipolar disorder; Major depressive disorder; Psychosis; Substance abuse; Clozapine; Olanzapine

Outcome Measures

Primary Outcomes (1)

• Frequencies of positive urine drug screens and breathalyzer alcohol levels

  Participants will have weekly urine drug screens and alcohol level measurement using breathalyzer to monitor ongoing substance and alcohol abuse.

  12 weeks

Secondary Outcomes (2)

• All-cause treatment discontinuation

  12 weeks

• Brief Psychiatric Rating Scale (BPRS) - Positive Psychopathology items

  12 weeks

Study Arms (2)

Clozapine Arm

EXPERIMENTAL

Drug: Clozapine

Olanzapine Arm

ACTIVE COMPARATOR

Drug: Olanzapine

Interventions

Clozapine DRUG

Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.

Clozapine Arm

Olanzapine DRUG

Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.

Olanzapine Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age, male or female (post-menopausal, surgically sterilized, or receiving either one of the listed contraception - depot contraceptive, Intrauterine device, or implanted hormonal contraceptive),
• who meet DSM-V criteria for schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, depression with psychotic features, or delusional disorder, and have ratings of Moderate or greater on at least one of the Brief Psychiatric Rating Scale psychosis items,
• who meet DSM-V criteria for at least one of alcohol, marijuana, cocaine, stimulant, or opioid use disorder, and have an admission urine drug screen positive for at least one of these substances,
• who have a stable living situation (family or supervised living, e.g. personal care home) to return to after release into the community,
• and who provide signed informed consent to participate (after testing for comprehension).

You may not qualify if:

• Prior failure to respond or tolerate clozapine or olanzapine
• Logistics that prevent outpatient follow-up at Serenity Behavioral Health Adult Outpatient services

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Sandarsh Surya

Evans, Georgia, 30809, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Substance-Related Disorders; Schizophrenia; Bipolar Disorder; Depressive Disorder, Major

Interventions

Clozapine; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry and Health Behavior

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 23, 2020

Record last verified: 2020-03

Locations

US (1)