Olanzapine in the Treatment of Patients With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Olanzapine in the Treatment of Low Weight and Obsessional Thinking Among Those With Anorexia Nervosa: A Double Blind Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260962
• Other study ID #: 2000210-01H
• Secondary ID: F1D-CA-O092
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2005
• Last updated: January 5, 2018
• Start date: September 2000
• Est. completion date: September 2006

Study information

• Verified date: January 2018
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.

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.

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline (week 2) and post-treatment (week 13)
Secondary	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.	Pretreatment (Week 1) and Posttreatment (Week 13)