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Olanzapine in the Treatment of Patients With Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00260962
First received: November 30, 2005
Last updated: September 30, 2009
Last verified: September 2009
  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 2

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:


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:
    Drug: Olanzapine
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Eating Disorders
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014