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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Diabetes Mellitus

Treatments

Drug: Olanzapine

Drug: Risperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00236379

CR002758

Details and patient eligibility

About

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.

Full 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

Enrollment

59 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.