Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients

• ClinicalTrials.gov Identifier: NCT00176436
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Results First Posted: June 17, 2013
• Last Update Posted: November 4, 2019
• Sponsor: University of Maryland, Baltimore
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): Robert Buchanan, University of Maryland, College Park

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Behavioral: Diet support group; Behavioral: Group counseling and exercise	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• 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
• Study Start Date: February 2004
• Actual Primary Completion Date: March 2008
• Actual Study Completion Date: March 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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 ]
2. Vital Signs [ Time Frame: Weekly for 24 weeks ]
3. Chemistry Panel [ Time Frame: baseline, 10 weeks and 24 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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

Locations

United States, Maryland

Maryland Psychiatric Research Center

Catonsville, Maryland, United States, 21228

Sponsors and Collaborators

University of Maryland, Baltimore

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 of Results:

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.

• Responsible Party: Robert Buchanan, Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland, College Park
• ClinicalTrials.gov Identifier: NCT00176436
• Other Study ID Numbers: H-21874; F1D-US-X254
• First Posted: September 15, 2005
• Results First Posted: June 17, 2013
• Last Update Posted: November 4, 2019
• Last Verified: May 2013

Keywords provided by Robert Buchanan, University of Maryland, College Park:

Weight loss; Support group; Exercise; Atomoxetine

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders