Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients - Full Text View

Sponsor:	University of Maryland
Collaborator:	Eli Lilly and Company
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00176436

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine

Resource links provided by NLM:

MedlinePlus related topics: Diets Exercise and Physical Fitness Schizophrenia Weight Control

Drug Information available for: Atomoxetine hydrochloride Atomoxetine Olanzapine Clozapine

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:

Primary outcome assessed is weight loss. [ Time Frame: Weekly for 24 weeks ] [ Designated as safety issue: No ]

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

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

No publications provided

Responsible Party:	Maryland Psychiatric Research Center/University of Maryland Baltimore ( M. Patricia Ball, R.N., C., M.S. )
Study ID Numbers:	H-21874, F1D-US-X254
Study First Received:	September 12, 2005
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00176436 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Maryland:

Weight loss
Support group
Exercise
Atomoxetine

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Atomoxetine
Antiemetics
Schizophrenia
Serotonin Antagonists
Mental Disorders
Therapeutic Uses

Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
GABA Antagonists
Serotonin Agents
Autonomic Agents
Clozapine
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009