Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2008-03-31

Brief Summary

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The study investigates the use of Atomoxetine in combination with exercise and a diet support group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder.

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Detailed Description

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The study is a 6 month double-blind trial of atomoxetine in combination with a Weight Watchers group to help patients lose the weight they have gained taking olanzapine or clozapine. All participants should have been on Olanzapine or clozapine for at least 6 months and gained 7% of baseline weight or have a BMI of 27 or greater. In addition to the group support, participants are provided supervised exercise sessions and medical supervision. Previous studies of the group process alone were successful in helping patients lose weight. It is hoped that the addition of atomoxetine, which is known to cause appetite suppression, will be more effective in helping subjects lose weight. All subjects will receive either atomoxetine or placebo during the 6 month study.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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active

Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24. Diet support group, group counseling and exercise.

Group Type ACTIVE_COMPARATOR

Group counseling and exercise

Intervention Type BEHAVIORAL

Support group weekly and exercise sessions 3 times/week for 24 weeks

Placebo

Placebo medication, diet support group, group counseling and exercise

Group Type PLACEBO_COMPARATOR

Diet support group

Intervention Type BEHAVIORAL

Diet support group weekly and exercise sessions 3 times/week, placebo medication

Interventions

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Diet support group

Diet support group weekly and exercise sessions 3 times/week, placebo medication

Intervention Type BEHAVIORAL

Group counseling and exercise

Support group weekly and exercise sessions 3 times/week for 24 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Schizophrenia or schizoaffective Disorder
* Taking olanzapine or clozapine for at least 6 months
* Weight gain of 7% over baseline or BMI greater than or equal to 27

Exclusion Criteria

* Current treatment with methylphenidate, clonidine, tricyclic antidepressants, bupropion and venlafaxine
* Treatment with other medications known to cause weight gain unless weight stable on medication for 6 months
* Current treatment with other medications for weight loss unless weight stable for 6 months
* Mental Retardation
* Alcohol or Substance Dependence within the last 6 months
* Pregnancy
* Alcohol or Substance Abuse within the lat month
* Uncontrolled hypertension defined as a blood pressure exceeding 140/90 on three consecutive readings despite adequate treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No