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Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Robert W. Buchanan, M.D., University of Maryland
ClinicalTrials.gov Identifier:
NCT00176436
First received: September 12, 2005
Last updated: May 7, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Maryland:

Primary Outcome Measures:
  • Change From Baseline in Weight [ Time Frame: Weekly for 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: Weekly for 24 weeks ] [ Designated as safety issue: Yes ]
  • Chemistry Panel [ Time Frame: baseline, 10 weeks and 24 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 12, 2005
Results First Received: January 18, 2013
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
Weight loss
Support group
Exercise
Atomoxetine

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Atomoxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014