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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236379
• Other study ID #: CR002758
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2005
• Last updated: May 16, 2011
• Est. completion date: August 2003

Study information

• Verified date: March 2011
• Source: Janssen, LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• Olanzapine
Target oral dose of 20 milligrams per day for 6 months
• Risperidone
Target oral dose of 6 milligrams per day for for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen, LP

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   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.