Trial intelligence / Profile preview

Olanzapine for Anorexia Nervosa in Children and Adolescents

NCT01184443Phase 3

Key facts

Status: Terminated
Start: Aug 2010
Primary completion: Aug 2013
Countries: 1
Sponsor: Children's Hospital of Eastern Ontario
Modality: Small Molecules

Drugs: olanzapine
Conditions: anorexia nervosa (AN)Eating Disorder Not Otherwise Specified (EDNOS)

Overview

Phase 3, open-label trial of olanzapine in anorexia nervosa (AN) and Eating Disorder Not Otherwise Specified (EDNOS) (2 arms), sponsored by Children's Hospital of Eastern Ontario. Primary endpoints: Eating Disorder Symptom Severity Scale at 12 weeks and Rate of weight gain at 12 weeks. Started Aug 2010; status: terminated.

Design

2 arms

Study design: Non-randomizedOpen-label

Olanzapine
Standard practice plus adjunctive olanzapine.
Comparison
Standard practice only.

Who it enrols

Adolescents 11-17 years old with Anorexia Nervosa or EDNOS and weight <= 85% of ideal body weight. Excludes those with diabetes, seizures, high blood pressure, or serious suicidal risk.

Endpoints

Primary

Eating Disorder Symptom Severity Scale12 weeks
Rate of weight gain12 weeks

Secondary

Children's Depression Inventory12 weeks
Multidimensional Anxiety Scale for Children12 weeks
Eating Disorder Examination Questionnaire-Adolescent12 weeks
The Children's Eating Attitudes Test12 weeks
Child Behavior Checklist12 weeks
Overall Safety Profile12 weeks

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