Clinical trial NCT00176436: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Weight loss
Support group
Exercise
Atomoxetine
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2005-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Weight
timeFrame: Weekly for 24 weeks
Secondary outcomes:
measure: Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.
timeFrame: 24 weeks
measure: Vital Signs
timeFrame: Weekly for 24 weeks
measure: Chemistry Panel
timeFrame: baseline, 10 weeks and 24 weeks
Other outcomes:
Locations:
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
Study officials:
affiliation: University of Maryland Baltimore Maryland Psychiatric Research Center
name: M Patricia Ball, R.N.,C.,M.S.
role: PRINCIPAL_INVESTIGATOR
References:
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.