Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Olanzapine in the Treatment of Patients With Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Dr. Hany Bissada, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00260962
First received: November 30, 2005
Last updated: March 19, 2017
Last verified: March 2017

November 30, 2005
March 19, 2017
September 2000
July 2006   (Final data collection date for primary outcome measure)
Body Mass Index (BMI) (kg/m^2) [ Time Frame: Baseline (week 2) and post-treatment (week 13) ]
Body Mass Index (BMI) measured in kg/m^2 units. Measured at Baseline (week 2) and post-treatment (week 13).
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
Obsessions [ Time Frame: Pretreatment (Week 1) and Posttreatment (Week 13) ]
Obsessions subscale of the Yale-Brown Obsessive Compulsive Scale. Minimum score is 0 and maximum score is 20. Higher scores indicate higher levels of obsessions.
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
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Anorexia Nervosa
  • Drug: Olanzapine
    After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
    Other Name: Zyprexa
  • Behavioral: Day Hospital
    Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
  • Placebo Comparator: Placebo
    Placebo and Treatment as usual (Day Hospital Program). After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
    Intervention: Behavioral: Day Hospital
  • Experimental: Olanzapine Plus Day Hospital
    After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
    Interventions:
    • Drug: Olanzapine
    • Behavioral: Day Hospital
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. doi: 10.1176/appi.ajp.2008.07121900. 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
34
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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00260962
2000210-01H
F1D-CA-O092 ( Other Identifier: Eli Lilly )
Not Provided
Not Provided
Undecided
Not Provided
Dr. Hany Bissada, Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Eli Lilly and Company
Principal Investigator: H Bissada OHRI
Ottawa Hospital Research Institute
March 2017

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