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

NCT00236379 | Completed Phase 4

• 1 other identifier: CR002758
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

  Up to 6 months

Study Arms (2)

001

EXPERIMENTAL

Risperidone Target oral dose of 6 milligrams per day for for 6 months

Drug: Risperidone

002

EXPERIMENTAL

Olanzapine Target oral dose of 20 milligrams per day for 6 months

Drug: Olanzapine

Interventions

Olanzapine DRUG

Target oral dose of 20 milligrams per day for 6 months

002

Risperidone DRUG

Target oral dose of 6 milligrams per day for for 6 months

001

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen, LP: lead

Related 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.

MeSH Terms

Conditions

Schizophrenia; Diabetes Mellitus

Interventions

Olanzapine; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Janssen, LP Clinical Trial

  Janssen, LP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Completion: August 1, 2003
• Last Updated: May 17, 2011

Record last verified: 2011-03