Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients

University of Maryland, Baltimore40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia

Interventions

Diet support groupBEHAVIORAL

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

Group counseling and exerciseBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, United States

Outcomes

Primary Outcomes

Change From Baseline in Weight

Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.

Time frame: Weekly for 24 weeks

Secondary Outcomes

Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.

Time frame: 24 weeks

Vital Signs

Time frame: Weekly for 24 weeks

Chemistry Panel

Time frame: baseline, 10 weeks and 24 weeks

Data from ClinicalTrials.gov

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