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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

November 30, 2005
September 30, 2009
September 2000
July 2006   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00260962 on ClinicalTrials.gov Archive Site
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 ]
The secondary outcome it the anti-obsessional and anti-anxiety properties to Olanzapine which could prove beneficial to Anorexia Nervosa patients.
Not Provided
Not Provided
 
Olanzapine in the Treatment of Patients With Anorexia Nervosa
Olanzapine in the Treatment of Low Weight and Obsessional Thinking Among Those With Anorexia Nervosa: A Double Blind Placebo Controlled Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Anorexia Nervosa
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.
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2006
July 2006   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00260962
2000210-01H, F1D-CA-O092
Not Provided
Hany Bissada, M.D., FRCP, The Ottawa Hospital, General Campus
Ottawa Hospital Research Institute
Eli Lilly and Company
Principal Investigator: H Bissada OHRI
Ottawa Hospital Research Institute
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP