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Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients

Phase 4
Completed
Conditions
Schizophrenia
Interventions
Behavioral: Diet support group
Behavioral: Group counseling and exercise
Registration Number
NCT00176436
Lead Sponsor
University of Maryland, Baltimore
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboDiet support groupPlacebo medication, diet support group, group counseling and exercise
activeGroup counseling and exerciseAtomoxetine 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.
Primary Outcome Measures
NameTimeMethod
Change From Baseline in WeightWeekly for 24 weeks

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.

Secondary Outcome Measures
NameTimeMethod
Chemistry Panelbaseline, 10 weeks and 24 weeks
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 SignsWeekly for 24 weeks

Trial Locations

Locations (1)

Maryland Psychiatric Research Center

🇺🇸

Catonsville, Maryland, United States

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