Olanzapine in the Treatment of Patients With Anorexia Nervosa

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 2

Conditions: Anorexia Nervosa

Treatments: Behavioral: Day Hospital; Drug: Olanzapine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00260962

F1D-CA-O092 (Other Identifier)

2000210-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

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.

Treatment:

Behavioral: Day Hospital

Olanzapine Plus Day Hospital

Experimental group

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.

Treatment:

Drug: Olanzapine

Behavioral: Day Hospital