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

• ClinicalTrials.gov Identifier: NCT00236379
• Recruitment Status: Completed
• First Posted: October 12, 2005
• Last Update Posted: May 17, 2011
• Sponsor: Janssen, LP
• Information provided by: Janssen, LP

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Diabetes Mellitus	Drug: Olanzapine; Drug: Risperidone	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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
• Actual Study Completion Date: August 2003

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test (which shows how the body regulates glucose) [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :

1. 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 [ Time Frame: Up to 6 months ]

Eligibility Criteria

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

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.

Contacts and Locations

Sponsors and Collaborators

Janssen, LP

Investigators

• Study Director: Janssen, LP Clinical Trial; Janssen, LP

More Information

Additional Information:

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. 

• ClinicalTrials.gov Identifier: NCT00236379
• Other Study ID Numbers: CR002758
• First Posted: October 12, 2005
• Last Update Posted: May 17, 2011
• Last Verified: March 2011

Keywords provided by Janssen, LP:

schizophrenia; blood glucose; glucose metabolism; diabetes mellitus; risperidone; olanzapine

Additional relevant MeSH terms:

Diabetes Mellitus; Schizophrenia; Psychotic Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Olanzapine; Risperidone; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators