Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Maryland Eli Lilly and Company |
---|---|
Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00176436 |
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.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Behavioral: Diet support group Behavioral: Group counseling and exercise |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine |
Enrollment: | 40 |
Study Start Date: | February 2004 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
active: Active Comparator
Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
|
Behavioral: Group counseling and exercise
Support group weekly and exercise sessions 3 times/week for 24 weeks
|
Placebo: Placebo Comparator
Placebo medication, diet support group weekly and exercise sessions 3 times/week
|
Behavioral: Diet support group
Diet support group weekly and exercise sessions 3 times/week, placebo medication
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Maryland Psychiatric Research Center | |
Catonsville, Maryland, United States, 21228 |
Principal Investigator: | M Patricia Ball, R.N.,C.,M.S. | University of Maryland Baltimore Maryland Psychiatric Research Center |
Responsible Party: | Maryland Psychiatric Research Center/University of Maryland Baltimore ( M. Patricia Ball, R.N., C., M.S. ) |
Study ID Numbers: | H-21874, F1D-US-X254 |
Study First Received: | September 12, 2005 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00176436 |
Health Authority: | United States: Food and Drug Administration |
Weight loss Support group Exercise Atomoxetine |
Schizophrenia Body Weight Mental Disorders Clozapine Weight Loss |
Olanzapine Atomoxetine Psychotic Disorders Weight Gain Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents |
Adrenergic Uptake Inhibitors Physiological Effects of Drugs Pharmacologic Actions |