Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism

NCT00287820

Schizophrenia Diabetes Metabolic Syndrome +1 more

COMPLETED PHASE4

Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia

NCT00802100

Schizophrenia

COMPLETED PHASE4

Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

NCT00910988

Hyperglycemia Hyperlipidemia

COMPLETED NA

Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

NCT00401973

Schizophrenia Schizoaffective Disorders

COMPLETED PHASE3

Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

NCT00088049

Schizophrenia

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Schizoaffective Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Olanzapine

Group Type EXPERIMENTAL

olanzapine

Intervention Type DRUG

5-20 mg, oral, capsules, daily, 12 weeks.

Risperidone

Group Type ACTIVE_COMPARATOR

risperidone

Intervention Type DRUG

2-6 mg, oral, capsules, twice daily (BID), 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

olanzapine

5-20 mg, oral, capsules, daily, 12 weeks.

Intervention Type DRUG

risperidone

2-6 mg, oral, capsules, twice daily (BID), 12 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY170053 Zyprexa

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-65 years old
* Diagnosed with Schizophrenia or Schizoaffective disorder
* Ability to visit the doctor's office for scheduled visits

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Have a body mass index (BMI) greater than 40
* Have diabetes, heart disease or any other unstable illness
* Have known positive human immunodeficiency virus (HIV)
* Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No