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Anti-psychotic

Olanzapine Group C 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 24 hours after administration of zyprexa

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 24 hours after administration of zyprexa

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours after administration of zyprexa

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after administration of zyprexa for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC extrapolated to infinity (AUC0-∞)

Area under the plasma drug concentration-time curve (AUC)

Maximum observed plasma drug concentration (Cmax)

Secondary outcome measures

AUC of ZYPREXA

Apparent plasma terminal elimination rate constant (λz) of ZYPREXA

Cmax of ZYPREXA

+2 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor

251 Previous Clinical Trials

3,485,283 Total Patients Enrolled

5 Trials studying Schizophrenia

1,672 Patients Enrolled for Schizophrenia

Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.

93 Previous Clinical Trials

38,686 Total Patients Enrolled

5 Trials studying Schizophrenia

1,672 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit on the number of individuals enrolled in this research endeavor?

"Indeed, information from clinicaltrials.gov confirms the ongoing patient recruitment for this medical trial. The initial posting date was on March 28th, 2024, with the most recent update occurring on April 4th of the same year. This study aims to enroll a total of 95 participants across a single research site."

Answered by AI

Is the study open to participants who are younger than 18 years old?

"Participants aged between 18 and 64 are eligible for inclusion in this research study. There are a total of 86 trials catering to individuals under the age of 18, while there are 229 trials available for those above 65 years old."

Answered by AI

What are the specific criteria for eligibility to partake in this study?

"Individuals aged between 18 and 64 years with a diagnosis of schizophrenia are eligible to participate in this clinical investigation, which aims to enroll a total of 95 volunteers."

Answered by AI

Is the enrollment process for this study currently ongoing?

"Affirmative, the details available on clinicaltrials.gov indicate that this research study is actively seeking volunteers. The trial was initially listed on March 28th, 2024 and recently revised on April 4th, 2024. To complete the study, they aim to recruit a total of 95 individuals from one designated site."

Answered by AI

What is the level of risk associated with Olanzapine Group C in individuals?

"Our assessment at Power rates the safety of Olanzapine Group C as a 1 on our scale. This rating is due to the preliminary nature of this Phase 1 trial, indicating there is minimal data available supporting its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder

2024. "Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06319170.

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