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

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ClinicalTrials.gov Identifier: NCT03857581
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Sandarsh Surya, Augusta University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psychosis Substance Use Disorders Drug: Clozapine Drug: Olanzapine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Clozapine Arm Drug: Clozapine
Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.
Active Comparator: Olanzapine Arm Drug: Olanzapine
Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.


Outcome Measures
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Primary Outcome Measures :
  1. Frequencies of positive urine drug screens and breathalyzer alcohol levels [ Time Frame: 12 weeks ]
    Participants will have weekly urine drug screens and alcohol level measurement using breathalyzer to monitor ongoing substance and alcohol abuse.


Secondary Outcome Measures :
  1. All-cause treatment discontinuation [ Time Frame: 12 weeks ]
    Discontinuation rate due to any cause (treatment non-compliance, worsening of mental health conditions, withdrawal of consent)

  2. Brief Psychiatric Rating Scale (BPRS) - Positive Psychopathology items [ Time Frame: 12 weeks ]

    BPRS scale is used to measure and monitor for symptoms of schizophrenia. For the purpose of the study, we will be measuring 4 items to monitor for positive psychopathology. The items are

    1. Suspiciousness
    2. Hallucinations
    3. Unusual thought content
    4. Conceptual disorganization

    Each item is rated on a scale of 1 to 7. 1 being condition not present and 7 being extreme form of the condition present. The maximum score a participant can score is 28 and minimum score is 4.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-60 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).

Exclusion Criteria:

  • Prior failure to respond or tolerate clozapine or olanzapine
  • Logistics that prevent outpatient follow-up at Serenity Behavioral Health Adult Outpatient services
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857581


Locations
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United States, Georgia
Sandarsh Surya
Evans, Georgia, United States, 30809
Contact: SANDARSH SURYA, MBBS    314-662-1682    ssurya@augusta.edu   
Contact: Joseph McEvoy, MD       jmcevoy@augusta.edu   
Sub-Investigator: Sandarsh Surya, MBBS         
Principal Investigator: Joseph McEvoy, MD         
Sponsors and Collaborators
Augusta University
More Information
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Responsible Party: Sandarsh Surya, Assistant Professor, Department of Psychiatry and Health Behavior, Augusta University
ClinicalTrials.gov Identifier: NCT03857581    
Other Study ID Numbers: 1303985
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sandarsh Surya, Augusta University:
Schizophrenia
Schizoaffective disorder
Bipolar disorder
Major depressive disorder
 Psychosis
Substance abuse
Clozapine
Olanzapine
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Chemically-Induced Disorders
Olanzapine
Clozapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
GABA Antagonists
GABA Agents