Clinical trial NCT00236379: A Study of the Effects of Risperidone and Olanzapine on Blood Glucose (Sugar) in Patients With Schizophrenia or Schizoaffective Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Diabetes Mellitus
Keywords: schizophrenia
blood glucose
glucose metabolism
diabetes mellitus
risperidone
olanzapine
Lead sponsor: Janssen, LP
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change in the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test (which shows how the body regulates glucose)
timeFrame: Up to 6 months
Secondary outcomes:
measure: 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
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Janssen, LP
name: Janssen, LP Clinical Trial
role: STUDY_DIRECTOR
References: