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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

Tracking Information
First Submitted Date  ICMJE February 26, 2019
First Posted Date  ICMJE February 28, 2019
Last Update Posted Date March 23, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
Frequencies of positive urine drug screens and blood alcohol levels [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • All-cause treatment discontinuation [ Time Frame: 12 weeks ]
  • Brief Psychiatric Rating Scale psychosis items [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder
Official Title  ICMJE Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Psychosis
  • Substance Use Disorders
Intervention  ICMJE
  • Drug: Clozapine
    Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.
  • Drug: Olanzapine
    Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.
Study Arms  ICMJE
  • Experimental: Clozapine Arm
    Intervention: Drug: Clozapine
  • Active Comparator: Olanzapine Arm
    Intervention: Drug: Olanzapine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03857581
Other Study ID Numbers  ICMJE 1303985
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sandarsh Surya, Augusta University
Study Sponsor  ICMJE Augusta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Augusta University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP