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Olanzapine in the Treatment of Patients With Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT00260962
Recruitment Status : Completed
First Posted : December 2, 2005
Results First Posted : April 28, 2017
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: Olanzapine Behavioral: Day Hospital Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2000
Actual Primary Completion Date : July 2006
Actual Study Completion Date : September 2006

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Arms and Interventions
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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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260962


Locations
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Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Eli Lilly and Company
Investigators
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Principal Investigator: H Bissada OHRI
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00260962    
Other Study ID Numbers: 2000210-01H
F1D-CA-O092 ( Other Identifier: Eli Lilly )
First Posted: December 2, 2005    Key Record Dates
Results First Posted: April 28, 2017
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ottawa Hospital Research Institute:
Pilot Project,
Clinical Trial,
Treatment Outcome,
Psychopharmacology
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents