Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clozapine Arm | Experimental |
| |
| Olanzapine Arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clozapine | Drug | Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause treatment discontinuation | Discontinuation rate due to any cause (treatment non-compliance, worsening of mental health conditions, withdrawal of consent) | 12 weeks |
| Brief Psychiatric Rating Scale (BPRS) - Positive Psychopathology items |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandarsh Surya | Evans | Georgia | 30809 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D019966 | Substance-Related Disorders |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
| D000068105 | Bipolar and Related Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003024 | Clozapine |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Olanzapine | Drug | Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits. |
|
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
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.
| 12 weeks |
| D019964 | Mood Disorders |
| D003866 | Depressive Disorder |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |