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Anti-psychotic
Extended-Release Olanzapine for Schizophrenia
Phase 1
Recruiting
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to understand how the body processes three different forms of olanzapine and to assess their safety and tolerability. It also seeks to evaluate how ZYPREXA is processed in the body
Who is the study for?
This trial is for adults with schizophrenia or schizoaffective disorder, confirmed by DSM-5 criteria. Participants must maintain their smoking status, weigh over 50 kg with a BMI of 18.5 to 38.0, and agree to inpatient stays. Women must test negative for pregnancy or be sterile/postmenopausal; men must be sterile or use birth control.
What is being tested?
The study aims to understand how the body processes three different olanzapine formulations used for treating schizophrenia/psychosis. It also assesses the safety and tolerability of these medications over a period of 19 weeks.
What are the potential side effects?
While not specified here, common side effects of olanzapine can include weight gain, drowsiness, increased appetite, restlessness, dry mouth, and constipation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Olanzapine Group CExperimental Treatment2 Interventions
Single-dose injection
Group II: Olanzapine Group BExperimental Treatment2 Interventions
Single-dose injection
Group III: Olanzapine Group AExperimental Treatment2 Interventions
Single-dose injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olanzapine
2005
Completed Phase 4
~5480
Find a Location
Who is running the clinical trial?
Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
255 Previous Clinical Trials
3,485,755 Total Patients Enrolled
5 Trials studying Schizophrenia
1,672 Patients Enrolled for Schizophrenia
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
96 Previous Clinical Trials
38,958 Total Patients Enrolled
5 Trials studying Schizophrenia
1,672 Patients Enrolled for Schizophrenia
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