search
Back to results

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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Depressive Disorder, Major

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
olanzapine versus risperidone
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring major depression with psychotic features, bipolar disorder with psychotic features

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for participation in the current research study. Subjects will be males and females between 18-60 years of age Subjects will have a definite diagnosis by DSM-IV criteria of schizophrenia, schizoaffective disorder, bipolar disorder or major depression with psychotic symptoms. Subjects may be outpatients or inpatients at the time of entry. They will continue in the study if hospitalization should occur. 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. 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.. Subject has received continuous treatment of olanzapine or risperidone in the last two months. 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. Subject has been diagnosed as treatment refractory. Subjects unable to speak or read the English language. 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. 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. 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. Subjects with clinical signs of liver disease should be excluded. 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. 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. Subjects with a known eating disorder Female subjects who are pregnant or breast-feeding Subjects who are being treated with a depot neuroleptic within one treatment cycle of the beginning of the washout period. Subjects with a history of neuroleptic malignant syndrome. Subjects with a high-risk for suicide.

Sites / Locations

  • Psychiatric Hospital at Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

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

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.

Full Information

First Posted
September 13, 2005
Last Updated
August 25, 2008
Sponsor
Vanderbilt University
search

1. Study Identification

Unique Protocol Identification Number
NCT00179062
Brief Title
Effects of Risperidone and Olanzapine on Patients With Schizophrenia, Schizoaffective Disorder, Major Depression or Bipolar Disorder
Official Title
Effects of Risperidone and Olanzapine on Weight Gain, Physical Health, and Outcome in a Community Sample of Severity and Persistently Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Depressive Disorder, Major, Bipolar Disorder
Keywords
major depression with psychotic features, bipolar disorder with psychotic features

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
olanzapine versus risperidone
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for participation in the current research study. Subjects will be males and females between 18-60 years of age Subjects will have a definite diagnosis by DSM-IV criteria of schizophrenia, schizoaffective disorder, bipolar disorder or major depression with psychotic symptoms. Subjects may be outpatients or inpatients at the time of entry. They will continue in the study if hospitalization should occur. 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. 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.. Subject has received continuous treatment of olanzapine or risperidone in the last two months. 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. Subject has been diagnosed as treatment refractory. Subjects unable to speak or read the English language. 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. 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. 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. Subjects with clinical signs of liver disease should be excluded. 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. 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. Subjects with a known eating disorder Female subjects who are pregnant or breast-feeding Subjects who are being treated with a depot neuroleptic within one treatment cycle of the beginning of the washout period. Subjects with a history of neuroleptic malignant syndrome. Subjects with a high-risk for suicide.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Y Meltzer, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21813074
Citation
Meltzer HY, Bonaccorso S, Bobo WV, Chen Y, Jayathilake K. A 12-month randomized, open-label study of the metabolic effects of olanzapine and risperidone in psychotic patients: influence of valproic acid augmentation. J Clin Psychiatry. 2011 Dec;72(12):1602-10. doi: 10.4088/JCP.10m05997. Epub 2011 Jul 12.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs