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

This study has been completed.
Sponsor:
Information provided by:
Janssen, LP
ClinicalTrials.gov Identifier:
NCT00236379
First received: October 7, 2005
Last updated: May 16, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Schizophrenia
Diabetes Mellitus
Drug: Olanzapine
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Janssen, LP:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 59
Study Completion Date: August 2003
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236379

Sponsors and Collaborators
Janssen, LP
Investigators
Study Director: Janssen, LP Clinical Trial Janssen, LP
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00236379     History of Changes
Other Study ID Numbers: CR002758
Study First Received: October 7, 2005
Last Updated: May 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen, LP:
schizophrenia
blood glucose
glucose metabolism
diabetes mellitus
risperidone
olanzapine

Additional relevant MeSH terms:
Schizophrenia
Diabetes Mellitus
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Olanzapine
Risperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 29, 2014