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| Sponsor: | Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00179062 |
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 |
| 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 |
Inclusion Criteria:
Subjects must meet all of the following criteria to be eligible for participation in the current research study.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from consideration for the current research project.
Contacts and Locations| United States, Tennessee | |
| Psychiatric Hospital at Vanderbilt | |
| Nashville, Tennessee, United States, 37212 | |
| Principal Investigator: | Herbert Y Meltzer, M.D. | Vanderbilt University |
More Information
| 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 |
|
major depression with psychotic features bipolar disorder with psychotic features |
|
Bipolar Disorder Depressive Disorder Depression Psychotic Disorders Schizophrenia Depressive Disorder, Major Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Schizophrenia and Disorders with Psychotic Features 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 Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics |