Atomoxetine for Weight-Loss Study

This  recruitment ended 03/01/08

Many antipsychotic medications cause significant weight gain. Obesity is a major health risk for heart disease and diabetes. As a follow-up to a previous non-medication study, this current study is a randomized, double-blind, placebo-controlled trial of the use of atomoxetine for weight loss in subjects who have gained weight secondary to new generation antipsychotic medications.

Atomoxetine (Strattera), FDA approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), was chosen primarily because it causes a decrease in appetite. A secondary rationale is to determine whether subjects who receive atomoxetine show improvement in memory and attention, cognitive deficits that have been observed in both schizophrenia and ADHD.

In addition to their study medications, subjects participate in a Weight Watchers Group weekly for 10 weeks and a similar follow-up group weekly for an additional 14 weeks. Participants are encouraged to exercise at least three times/week, and supervised exercise sessions will be provided as part of the study. Regular medical screening and monitoring are part of the study.

To be eligible for the study, subjects must:

• have a diagnosis of Schizophrenia or Schizoaffective Disorder
• be an outpatient
• be taking olanzapine or clozapine for at least 6 months
• gained at least 7% of their baseline weight
• be between the ages of 18 and 65

Patients will be screened to be sure that their weight gain is probably due to treatment with olanzapine or clozapine and not due to other medical conditions or other medications they are taking.

For further information, please contact Pat Ball, R.N., C., M.S. at 410-402-7663 or pball@mprc.umaryland.edu.

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