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Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176436
First Posted: September 15, 2005
Last Update Posted: June 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Robert W. Buchanan, M.D., University of Maryland
  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.

Condition Intervention Phase
Schizophrenia Behavioral: Diet support group Behavioral: Group counseling and exercise Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine

Resource links provided by NLM:


Further study details as provided by Robert W. Buchanan, M.D., University of Maryland:

Primary Outcome Measures:
  • Change From Baseline in Weight [ Time Frame: Weekly for 24 weeks ]
    Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.


Secondary Outcome Measures:
  • Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function. [ Time Frame: 24 weeks ]
  • Vital Signs [ Time Frame: Weekly for 24 weeks ]
  • Chemistry Panel [ Time Frame: baseline, 10 weeks and 24 weeks ]

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 Comparator: active
Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24. Diet support group, group counseling and exercise.
Behavioral: Group counseling and exercise
Support group weekly and exercise sessions 3 times/week for 24 weeks
Placebo Comparator: Placebo
Placebo medication, diet support group, group counseling and exercise
Behavioral: Diet support group
Diet support group weekly and exercise sessions 3 times/week, placebo medication

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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176436


Locations
United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
Eli Lilly and Company
Investigators
Principal Investigator: M Patricia Ball, R.N.,C.,M.S. University of Maryland Baltimore Maryland Psychiatric Research Center
  More Information

Publications:
Responsible Party: Robert W. Buchanan, M.D., Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland
ClinicalTrials.gov Identifier: NCT00176436     History of Changes
Other Study ID Numbers: H-21874
F1D-US-X254
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: January 18, 2013
Results First Posted: June 17, 2013
Last Update Posted: June 17, 2013
Last Verified: May 2013

Keywords provided by Robert W. Buchanan, M.D., University of Maryland:
Weight loss
Support group
Exercise
Atomoxetine

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Clozapine
Atomoxetine Hydrochloride
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Serotonin Antagonists
GABA Antagonists
GABA Agents