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

Phase 4

Completed

• Conditions: Schizophrenia; Diabetes Mellitus
• Interventions: Drug: Risperidone; Drug: Olanzapine

• Registration Number: NCT00236379
• Lead Sponsor: Janssen, LP

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

Study Timeline

• Study Completion: 2003-08
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-05-16
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
001	Risperidone	Risperidone Target oral dose of 6 milligrams per day for for 6 months
002	Olanzapine	Olanzapine Target oral dose of 20 milligrams per day for 6 months

Primary Outcome Measures

Name	Time	Method
Change in the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test (which shows how the body regulates glucose)	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Changes in measurements of metabolism and glucose regulation; changes in results of tests and questionnaires evaluating the effectiveness and safety (including laboratory tests and anthropomatic measurements) of medications used to treat schizophrenia	Up to 6 months