Olanzapine in the Treatment of Patients With Anorexia Nervosa

Phase 2

Completed

• Conditions: Anorexia Nervosa
• Interventions: Drug: Olanzapine; Behavioral: Day Hospital

• Registration Number: NCT00260962
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2005-11-30
• Study First Submitted QC: 2005-11-30
• Study First Posted: 2005-12-02
• Primary Completion: 2006-07
• Study Completion: 2006-09
• Results First Submitted: 2017-01-26
• Results First Submitted QC: 2017-03-19
• Results First Posted: 2017-04-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine Plus Day Hospital	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.
Placebo	Day Hospital	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.
Olanzapine Plus Day Hospital	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 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.

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI) (kg/m^2)	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

Name	Time	Method
Obsessions	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.

Trial Locations

Locations (1)

Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada