Olanzapine in the Treatment of Patients With Anorexia Nervosa

January 5, 2018 updated by: Ottawa Hospital Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.
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 Names:
  • Zyprexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (week 2) and post-treatment (week 13)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pretreatment (Week 1) and Posttreatment (Week 13)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: H Bissada, OHRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria

November 30, 2005

First Posted (Estimate)

December 2, 2005

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000210-01H
  • F1D-CA-O092 (Other Identifier: Eli Lilly)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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