Back to resultsAtomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Diet support group
Group counseling and exercise
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Weight loss, Support group, Exercise, Atomoxetine
Eligibility 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
Sites / Locations
- Maryland Psychiatric Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
active
Placebo
Arm Description
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.
Placebo medication, diet support group, group counseling and exercise
Outcomes
Primary Outcome Measures
Change From Baseline in Weight
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.
Vital Signs
Chemistry Panel
Full Information
NCT ID
NCT00176436
First Posted
September 12, 2005
Last Updated
March 1, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00176436
Brief Title
Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients
Official Title
Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Weight loss, Support group, Exercise, Atomoxetine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo medication, diet support group, group counseling and exercise
Intervention Type
Behavioral
Intervention Name(s)
Diet support group
Intervention Description
Diet support group weekly and exercise sessions 3 times/week, placebo medication
Intervention Type
Behavioral
Intervention Name(s)
Group counseling and exercise
Intervention Description
Support group weekly and exercise sessions 3 times/week for 24 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Weight
Description
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.
Time Frame
Weekly for 24 weeks
Secondary Outcome Measure Information:
Title
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
Title
Vital Signs
Time Frame
Weekly for 24 weeks
Title
Chemistry Panel
Time Frame
baseline, 10 weeks and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Patricia Ball, R.N.,C.,M.S.
Organizational Affiliation
University of Maryland Baltimore Maryland Psychiatric Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryland Psychiatric Research Center
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21459735
Citation
Ball MP, Warren KR, Feldman S, McMahon RP, Kelly DL, Buchanan RW. Placebo-controlled trial of atomoxetine for weight reduction in people with schizophrenia treated with clozapine or olanzapine. Clin Schizophr Relat Psychoses. 2011 Apr;5(1):17-25. doi: 10.3371/CSRP.5.1.3.
Results Reference
result
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Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients
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