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Evaluation of the Efficacy and Safety of Olanzapine for Anorexia Nervosa in Children and Adolescents

NCT01184443 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2014-09-04

No results posted yet for this study

Summary

The purpose of this trial is to evaluate the safety and efficacy of the atypical antipsychotic, olanzapine, for the treatment of youth suffering from Anorexia Nervosa (AN).

Adolescent males and females between the ages of 11 and 17 years who are being treated by a physician on the Eating Disorder team at the Children's Hospital of Eastern Ontario will be invited to join the study if they have been diagnosed with AN or Eating Disorder Not Otherwise Specified (EDNOS), and if they weigh less than or equal to 85% of their ideal body weight. Those who meet inclusion and not exclusion criteria, and consent to participating in the trial will be offered adjunctive treatment with olanzapine. Those who agree to take olanzapine will belong to the olanzapine group, and those who decline will belong to the comparison group. Olanzapine doses will be in keeping with the investigators current clinical practice, with flex doses ranging from 1.25 mg to 10.0 mg daily (the majority of patients are treated with 2.5 mg or 5.0 mg at bedtime); dose adjustments made based on individual need and tolerability. Participants will remain in the study for 12 weeks. Those who initially decline olanzapine treatment may change their minds and take olanzapine up until week 9 of the trial.

It is hypothesized that those children and adolescents who choose to take olanzapine at entry into the trial will be more motivated to recover and more compliant with treatment. Compared to those who do not receive medication, it is expected that these adolescents will demonstrate reduced disordered eating attitudes and behaviours, as well as an increased rate of weight gain.

Finally, it is predicted that the rates of discontinuation and the adverse effects of olanzapine will be minor given the relatively low dose (as compared to treatment for patients with schizophrenia), slow titration, and short-term use of olanzapine the investigators will be using.

By comparing the well-being and outcome of patients in the two groups, the investigators hope to begin to answer the question of whether olanzapine does or does not lead to improved clinical outcome for patients with severe eating disorders such as AN or EDNOS, and the question of whether the benefits of using the medication outweigh the risks.

Conditions

  • Eating Disorder

Interventions

DRUG

Olanzapine

Dosing regimen is in keeping with clinical practice. Patients will typically start oral olanzapine at 2.5mg (rarely 1.25mg) daily for 1 to 2 weeks, and if tolerated and clinically indicated, are increased to 5.0mg daily. The majority of patients will remain on a maintenance dose of 5.0mg, but more agitated patients may take 7.5mg (rarely 10.0mg) daily. Patients will be tapered off as they approach/attain their ideal body weight.

Sponsors & Collaborators

  • Children's Hospital of Eastern Ontario

    lead OTHER

Principal Investigators

  • Wendy J Spettigue, MD, FRCPC · Children's Hospital of Eastern Ontario

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-08-31
Completion
2014-03-31

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01184443 on ClinicalTrials.gov