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Atypical Antipsychotic
Clozapine Arm for Psychosis
Phase 4
Waitlist Available
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This study is evaluating whether clozapine may be more effective than olanzapine for individuals with psychotic disorder and substance use disorder.
Eligible Conditions
- Psychosis
- Substance Use Disorder
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequencies of positive urine drug screens and breathalyzer alcohol levels
Secondary outcome measures
All-cause treatment discontinuation
Brief Psychiatric Rating Scale (BPRS) - Positive Psychopathology items
Side effects data
From 2008 Phase 4 trial • 25 Patients • NCT0000165631%
Increased appetite
31%
Hypersalivation
17%
tachycardia >100 beats/min (supine)
15%
Somnolence
15%
Constipation
9%
Hypertension
8%
Difficulty concentrating
8%
Enuresis
8%
Insomnia
8%
Abnormal white blood count
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olanzapine Group
Clozapine Group
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Clozapine ArmExperimental Treatment1 Intervention
Group II: Olanzapine ArmActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clozapine
FDA approved
Find a Location
Who is running the clinical trial?
Augusta UniversityLead Sponsor
211 Previous Clinical Trials
84,968 Total Patients Enrolled
1 Trials studying Psychosis
23 Patients Enrolled for Psychosis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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