Back to resultsOlanzapine in the Treatment of Patients With Anorexia Nervosa
Primary Purpose
Anorexia Nervosa
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Olanzapine
Day Hospital
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring Pilot Project,, Clinical Trial,, Treatment Outcome,, Psychopharmacology
Eligibility 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.
Sites / Locations
- Ottawa Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Olanzapine Plus Day Hospital
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Body Mass Index (BMI) (kg/m^2)
Body Mass Index (BMI) measured in kg/m^2 units. Measured at Baseline (week 2) and post-treatment (week 13).
Secondary Outcome Measures
Obsessions
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.
Full Information
NCT ID
NCT00260962
First Posted
November 30, 2005
Last Updated
January 5, 2018
Sponsor
Ottawa Hospital Research Institute
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00260962
Brief Title
Olanzapine in the Treatment of Patients With Anorexia Nervosa
Official Title
Olanzapine in the Treatment of Low Weight and Obsessional Thinking Among Those With Anorexia Nervosa: A Double Blind Placebo Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Pilot Project,, Clinical Trial,, Treatment Outcome,, Psychopharmacology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Olanzapine Plus Day Hospital
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Day Hospital
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index (BMI) (kg/m^2)
Description
Body Mass Index (BMI) measured in kg/m^2 units. Measured at Baseline (week 2) and post-treatment (week 13).
Time Frame
Baseline (week 2) and post-treatment (week 13)
Secondary Outcome Measure Information:
Title
Obsessions
Description
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.
Time Frame
Pretreatment (Week 1) and Posttreatment (Week 13)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H Bissada
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18558642
Citation
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.
Results Reference
derived
Learn more about this trial
Olanzapine in the Treatment of Patients With Anorexia Nervosa
We'll reach out to this number within 24 hrs