Back to resultsAssessment of a Weight Management Program for Weight Gain in Patients With Schizophrenia
Primary Purpose
Schizophrenic Disorders
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Olanzapine Hydrochloride
Weight Management Program
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenic Disorders
Eligibility Criteria
Inclusion Criteria:
- Male and female patients between the ages of 18 and 65 years (inclusive)
- Subjects must meet the DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder
- Subjects must have been treated with olanzapine (5 to 20 mg/day) for at least 12 weeks prior to study entry and who experienced a weight gain of greater than or equal to 7% of body weight during olanzapine treatment
Exclusion Criteria:
- Treatment with an injectable depot neuroleptic 14 days before visit 1
- Subjects with an PANSS score greater than 70
- One or more seizures without a clear and unresolved etiology
- Known diagnosis of DSM-IV substance dependence (except nicotine and caffeine) within the past 2 months, which in the opinion of the investigator is affecting the diet and/or weight of the subject
- As a result of liver function test, ALT/AST ranges are shown twice the upper limit of the normal reference range
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Outcomes
Primary Outcome Measures
Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group
Secondary Outcome Measures
Mean change from baseline to endpoint in the Stunkard and Messick Eating Inventory
Measure safety parameters, including medical history, psychiatric and physical examinations, vital signs (blood pressure, pulse and weight), clinical laboratory tests and record of symptoms
Severity of psychiatric symptoms and extrapyramidal symptoms were monitored using the PANSS and the AIMS, respectively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00485823
Brief Title
Assessment of a Weight Management Program for Weight Gain in Patients With Schizophrenia
Official Title
The Assessment of a Weight Management Program for Treatment-Emergent Weight Gain in Patients With Schizophrenia, Schizophreniform Disorder, and Schizoaffective Disorder During Olanzapine Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to develop the weight management program, which is combined with healthy diet, proper physical exercise, and behavior modification, related to patient's quality of life. The patients groups are in routine practice with 5-20 mg olanzapine. The study results may be utilized for patients who have gained weight on olanzapine and also other antipsychotic drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Olanzapine Hydrochloride
Intervention Type
Procedure
Intervention Name(s)
Weight Management Program
Primary Outcome Measure Information:
Title
Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group
Secondary Outcome Measure Information:
Title
Mean change from baseline to endpoint in the Stunkard and Messick Eating Inventory
Title
Measure safety parameters, including medical history, psychiatric and physical examinations, vital signs (blood pressure, pulse and weight), clinical laboratory tests and record of symptoms
Title
Severity of psychiatric symptoms and extrapyramidal symptoms were monitored using the PANSS and the AIMS, respectively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients between the ages of 18 and 65 years (inclusive)
Subjects must meet the DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder
Subjects must have been treated with olanzapine (5 to 20 mg/day) for at least 12 weeks prior to study entry and who experienced a weight gain of greater than or equal to 7% of body weight during olanzapine treatment
Exclusion Criteria:
Treatment with an injectable depot neuroleptic 14 days before visit 1
Subjects with an PANSS score greater than 70
One or more seizures without a clear and unresolved etiology
Known diagnosis of DSM-IV substance dependence (except nicotine and caffeine) within the past 2 months, which in the opinion of the investigator is affecting the diet and/or weight of the subject
As a result of liver function test, ALT/AST ranges are shown twice the upper limit of the normal reference range
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Assessment of a Weight Management Program for Weight Gain in Patients With Schizophrenia
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