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CompletedNCT00485823Updated Jun 13, 2007

Assessment of a Weight Management Program for Weight Gain in Patients With Schizophrenia

A Phase 4 interventional study of Olanzapine Hydrochloride and Weight Management Program in Schizophrenic Disorders, sponsored by Eli Lilly and Company. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-06-13.

Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenic Disorders
03

In context

Weight Gain

405 studies on the registry are indexed under Weight Gain; 52 are open to participants now.

This study's enrollment of 48 is below the median of 83 across 324 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Interventions

  • DrugOlanzapine Hydrochloride
  • ProcedureWeight Management Program
06

What researchers measure

Primary outcomes

  1. Comparison in the change in body weight from baseline to endpoint in the intervention group versus the control group

Secondary outcomes

  1. Mean change from baseline to endpoint in the Stunkard and Messick Eating Inventory

  2. Measure safety parameters, including medical history, psychiatric and physical examinations, vital signs (blood pressure, pulse and weight), clinical laboratory tests and record of symptoms

  3. Severity of psychiatric symptoms and extrapyramidal symptoms were monitored using the PANSS and the AIMS, respectively.

07

Study locations

1 site
  • 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.
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00485823
Lead sponsor
Eli Lilly and Company
First posted
Jun 13, 2007
Start date
Dec 2002
Completion
Sep 2003
Last update
Jun 13, 2007

Study contacts

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)
study director · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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