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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Schizophrenia
• Intervention / Treatment: Drug: Risperidone; Drug: Olanzapine

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 001; Risperidone Target oral dose of 6 milligrams per day for for 6 months	Drug: Risperidone; Target oral dose of 6 milligrams per day for for 6 months
Experimental: 002; Olanzapine Target oral dose of 20 milligrams per day for 6 months	Drug: Olanzapine; Target oral dose of 20 milligrams per day for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Janssen, LP

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion (Actual): August 1, 2003

Study Registration Dates

• First Submitted: October 7, 2005
• First Submitted That Met QC Criteria: October 7, 2005
• First Posted (Estimate): October 12, 2005

Study Record Updates

• Last Update Posted (Estimate): May 17, 2011
• Last Update Submitted That Met QC Criteria: May 16, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: schizophrenia; olanzapine; risperidone; blood glucose; diabetes mellitus; glucose metabolism
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Diabetes Mellitus; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Olanzapine; Risperidone
• Other Study ID Numbers: CR002758

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No