A Study of the Effects of Risperidone and Olanzapine on Blood Glucose (Sugar) in Patients With Schizophrenia or Schizoaffective Disorder

NCT ID: NCT00236379

Last Updated: 2011-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2003-08-31

Brief Summary

The purpose of this study is to assess and compare how risperidone and olanzapine, two antipsychotic medications, affect the regulation of glucose (sugar) in the body.

Detailed Description

The newer antipsychotic medications risperidone and olanzapine effectively treat schizophrenia and related disorders, and they may cause fewer side effects than the older antipsychotic drugs do. However, some of the newer antipsychotic medications could have a negative effect on the regulation of blood glucose (sugar) in the body. This negative effect could make the patient gain weight and even develop diabetes mellitus. This randomized, double-blind study will assess and compare how risperidone and olanzapine affect the regulation of glucose in the body in patients with schizophrenia and schizoaffective disorder. Patients will be randomly assigned to receive risperidone (target oral dose of 6 milligrams per day) or olanzapine (target oral dose of 20 milligrams per day) for 6 months. Repeat laboratory measurements will be performed and questions will be asked of the patients to evaluate the safety and effectiveness of the drugs. The primary laboratory test used to assess the patient's regulation of blood glucose will be the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test. Risperidone 2 milligram oven-encapsulated tablets taken orally once a day for 6 months; olanzapine 5 milligram tablets taken orally once a day for 6 months

Conditions

Schizophrenia; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

001

Risperidone Target oral dose of 6 milligrams per day for for 6 months

Group Type: EXPERIMENTAL

Risperidone

Intervention Type: DRUG

Target oral dose of 6 milligrams per day for for 6 months

002

Olanzapine Target oral dose of 20 milligrams per day for 6 months

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Target oral dose of 20 milligrams per day for 6 months

Interventions

Olanzapine

Target oral dose of 20 milligrams per day for 6 months

Intervention Type: DRUG

Risperidone

Target oral dose of 6 milligrams per day for for 6 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of schizophrenia or related disorder
• stable with respect to disease symptoms and other medical conditions
• would benefit from this type of antipsychotic drug
• if female, using birth control.

Exclusion Criteria

• Patients who are delirious, bipolar, severely mentally retarded, or suicidal
• psychiatric diagnosis of disease unrelated to schizophrenia
• presence of stroke, brain tumor, Parkinson's Disease, or diseases that affect blood glucose control
• history of diabetes
• long or recent history of taking risperidone, olanzapine, quetiapine, clozapine, or investigational drugs
• recent history of unstable thyroid function
• if female, not using birth control
• abusing drugs or alcohol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, LP

INDUSTRY

Sponsor Role: lead

Principal Investigators

Janssen, LP Clinical Trial

Role: STUDY_DIRECTOR

Janssen, LP

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=345&filename=CR002758_CSR.pdf

A Six-Month, Double Blind, Randomized, International, Multicenter Trial to Evaluate the Glucoregulatory Effects of Risperidone and Olanzapine in Subjects with Schizophrenia or Schizoaffective disorder.

Other Identifiers

CR002758

Identifier Type: -

Identifier Source: org_study_id