Clinical trial NCT00485823: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenic Disorders
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group
Secondary outcomes:
measure: Mean change from baseline to endpoint in the Stunkard and Messick Eating Inventory
measure: Measure safety parameters, including medical history, psychiatric and physical examinations, vital signs (blood pressure, pulse and weight), clinical laboratory tests and record of symptoms
measure: Severity of psychiatric symptoms and extrapyramidal symptoms were monitored using the PANSS and the AIMS, respectively.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: