Effects of Risperidone and Olanzapine on Patients With Schizophrenia, Schizoaffective Disorder, Major Depression or Bipolar Disorder

August 25, 2008 updated by: Vanderbilt University

Effects of Risperidone and Olanzapine on Weight Gain, Physical Health, and Outcome in a Community Sample of Severity and Persistently Ill Patients

This twelve month, open-label study considers the effect of Risperdal (risperidone) versus Zyprexa (olanzapine) on weight gain, physical health, and outcome in a population of those diagnosed with schizophrenia, schizoaffective disorder, major depression or bipolar disorder with psychotic features. This study evaluates symptom response as well as general health indicators such as body mass index, glucose, prolactin, and cholesterol levels at baseline, month (M)1, M3, M6 and M12.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Psychiatric Hospital at Vanderbilt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for participation in the current research study.

  1. Subjects will be males and females between 18-60 years of age
  2. Subjects will have a definite diagnosis by DSM-IV criteria of schizophrenia, schizoaffective disorder, bipolar disorder or major depression with psychotic symptoms.
  3. Subjects may be outpatients or inpatients at the time of entry. They will continue in the study if hospitalization should occur.
  4. The subjects or their legal guardian must sign the informed consent form.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from consideration for the current research project.

  1. Subjects will be excluded if they have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis other than schizophrenia, schizoaffective disorder, bipolar disorder or depression with psychotic features; however, a concurrent diagnosis of post-traumatic stress disorder, which does not account for the subjects's psychosis is acceptable..
  2. Subject has received continuous treatment of olanzapine or risperidone in the last two months.
  3. Subjects receiving continuous treatment with olanzapine or risperidone in the last two months prior to entering the study will be excluded. This means the subject cannot have actually taken olanzapine or risperidone daily for more than four weeks prior to enrollment. There must be a gap of at least two days of not taking medication during that period. The dose for olanzapine cannot exceed 10 mg /day, the dose for risperidone 2 mg/day. The last day of exposure of any kind should be at least seven days before baseline.
  4. Subject has been diagnosed as treatment refractory.
  5. Subjects unable to speak or read the English language.
  6. Subjects with a DSM-IV diagnosis of substance dependence within three months prior to selection. Occasional abuse (defined as bingeing no more than once per week) will not preclude entry.
  7. Subjects with a documented disease of the central nervous system, including but not limited to stroke, tumor, Parkinson's disease, Alzheimer's disease, Huntington's disease, seizure disorder requiring anticonvulsants, history of brain trauma resulting in documented impairment, chronic infection, neurosyphilis.
  8. Subjects with hepatic, renal, atherosclerotic heart disease, arrhythmias or gastrointestinal disease of sufficient degree to interfere with the excretion, absorption, and/or metabolism of trial medication.
  9. Subjects with clinical signs of liver disease should be excluded.
  10. Subjects with acute (e.g. infection), unstable (e.g. labile hypertension, unstable angina), significant, or untreated medical illness; patients with diastolic blood pressure > 95 mmHg at screening should be treated and stabilized before randomization.
  11. Subjects with narrow angle glaucoma, chronic urinary retention and/or clinically significant prostatic hypertrophy, paralytic ileus or related conditions, which in the opinion of the investigator may be exacerbated by the anticholinergic effects of olanzapine.
  12. Subjects with a known eating disorder
  13. Female subjects who are pregnant or breast-feeding
  14. Subjects who are being treated with a depot neuroleptic within one treatment cycle of the beginning of the washout period.
  15. Subjects with a history of neuroleptic malignant syndrome.
  16. Subjects with a high-risk for suicide.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: olanzapine versus risperidone
Participants are to be randomized to olanzapine or risperidone. Antipsychotic medication will be given as per package insert daily for the twelve month duration of the trial.
Active Comparator: 1
Drug: olanzapine versus risperidone
Participants are to be randomized to olanzapine or risperidone. Antipsychotic medication will be given as per package insert daily for the twelve month duration of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the main and interactional effects of risperidone and olanzapine on body mass index (BMI), other measures of obesity, and other health-related factors, including total cholesterol, lipid panels, blood glucose, glycohemoglobin, and prolactin
Time Frame: twelve months
twelve months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine primary drug treatment effects and the relationships between change in BMI (body mass index), the biological measures listed above, and clinical outcomes including several domains of functioning.
Time Frame: twelve months
twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Herbert Y Meltzer, M.D., Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

August 26, 2008

Last Update Submitted That Met QC Criteria

August 25, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 990472

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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