Olanzapine in the Treatment of Patients With Anorexia Nervosa - Full Text View

Sponsor:	Ottawa Hospital Research Institute
Collaborator:	Eli Lilly and Company
Information provided by:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00260962

Purpose

The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.

Condition	Intervention	Phase
Anorexia Nervosa	Drug: Olanzapine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Olanzapine in the Treatment of Low Weight and Obsessional Thinking Among Those With Anorexia Nervosa: A Double Blind Placebo Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:

The primary outcome of this study is to evaluate the Olanzapine weight gain effect, when administered to Anorexia Nervosa patients in order to facilitate the desired weight component of their nutritional rehabilitation. [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcome it the anti-obsessional and anti-anxiety properties to Olanzapine which could prove beneficial to Anorexia Nervosa patients. [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	September 2000
Study Completion Date:	September 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Double blind, placebo controlled drug trial with 14 subjects randomized to Olanzapine,14 randomized to placebo. Olanzapine was started at 2.5 mg/day and titrated slowly (2.5 mg/week) to a maximum of 10 mg/day. Drug or placebo given daily for 10 weeks.

Detailed Description:

The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

those who meet DSM IV criteria of Anorexia Nervosa- either restricting or binge/purge subtype

Exclusion Criteria:

patients who are actively self destructive and/or suicidal
patients whose medical status is seriously compromised
patients whose eating disorder is superimposed on a major psychiatric disorder such as schizophrenia, major affective disorders, dissociative disorder or an active substance abuse disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260962

Locations

Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9

Sponsors and Collaborators

Ottawa Hospital Research Institute

Eli Lilly and Company

Investigators

Principal Investigator:

H Bissada

OHRI

More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bissada H, Tasca GA, Barber AM, Bradwejn J. Olanzapine in the treatment of low body weight and obsessive thinking in women with anorexia nervosa: a randomized, double-blind, placebo-controlled trial. Am J Psychiatry. 2008 Oct;165(10):1281-8. Epub 2008 Jun 16.

Responsible Party:	Hany Bissada, M.D., FRCP, The Ottawa Hospital, General Campus
ClinicalTrials.gov Identifier:	NCT00260962 History of Changes
Other Study ID Numbers:	2000210-01H, F1D-CA-O092
Study First Received:	November 30, 2005
Last Updated:	September 30, 2009
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:

Pilot Project,
Clinical Trial,
Treatment Outcome,
Psychopharmacology

Additional relevant MeSH terms:

Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012