Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients

Study Overview
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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.

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.

Official Title
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Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Diet support group
* Behavioral: Group counseling and exercise


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active<br>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. | Behavioral: Group counseling and exercise<br>* Support group weekly and exercise sessions 3 times/week for 24 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo medication, diet support group, group counseling and exercise | Behavioral: Diet support group<br>* Diet support group weekly and exercise sessions 3 times/week, placebo medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Weekly for 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function. |  | 24 weeks | 
| Vital Signs |  | Weekly for 24 weeks | 
| Chemistry Panel |  | baseline, 10 weeks and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Support group, Exercise, Atomoxetine