Status:
COMPLETED
Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00176436
Start Date
February 1 2004
End Date
March 1 2008
Last Update
March 14 2022
Active Locations (1)
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1
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228