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

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179062
First received: September 13, 2005
Last updated: August 25, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Depressive Disorder, Major
Bipolar Disorder
Drug: olanzapine versus risperidone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Risperidone and Olanzapine on Weight Gain, Physical Health, and Outcome in a Community Sample of Severity and Persistently Ill Patients

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: February 2000
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00179062

Locations
United States, Tennessee
Psychiatric Hospital at Vanderbilt
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Herbert Y Meltzer, M.D. Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Herbert Meltzer, M.D. - principal investigator, Vanderbilt Medical Center
ClinicalTrials.gov Identifier: NCT00179062     History of Changes
Other Study ID Numbers: 990472
Study First Received: September 13, 2005
Last Updated: August 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
major depression with psychotic features
bipolar disorder with psychotic features

Additional relevant MeSH terms:
Depressive Disorder
Depression
Schizophrenia
Bipolar Disorder
Disease
Psychotic Disorders
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Affective Disorders, Psychotic
Pathologic Processes
Risperidone
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics

ClinicalTrials.gov processed this record on October 02, 2014