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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Olanzapine Hydrochloride

Intervention Type DRUG

Weight Management Program

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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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

Eli Lilly and Company

Locations

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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, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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F1D-KL-S031

Identifier Type: -

Identifier Source: secondary_id

6696