Catonsville, Maryland 21228

  • Schizophrenia

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00176436


Primary Contact:

Principal Investigator
M Patricia Ball, R.N.,C.,M.S.
University of Maryland Baltimore Maryland Psychiatric Research Center


Backup Contact:

N/A


Location Contact:

Catonsville, Maryland 21228
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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