Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients
Information source: University of Maryland
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Diet support group (Behavioral); Group counseling and exercise (Behavioral)
Phase: Phase 4
Status: Completed
Sponsored by: University of Maryland Official(s) and/or principal investigator(s):
M Patricia Ball, R.N.,C.,M.S., Principal Investigator, Affiliation: University of Maryland Baltimore Maryland Psychiatric Research Center
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.
Clinical Details
Official title: Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Primary outcome assessed is weight loss.
Secondary outcome: Secondary outcomes are improvement in cognitive impairments, since atomoxetine is used for treatment of ADHD and is known to improve cognitive function.Vital signs Chemistry panel
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Maryland Psychiatric Research Center, Catonsville, Maryland 21228, United States
Additional Information
Starting date: February 2004
Ending date: March 2008
Last updated: April 22, 2008
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