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

September 3, 2014 updated by: Wendy Spettigue, Children's Hospital of Eastern Ontario

Evaluation of the Efficacy and Safety of Olanzapine as an Adjunctive Treatment for Anorexia Nervosa in Children and Adolescents: An Open-label Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female between 11 and 17 (less than 18) at beginning of trial
  • Based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), patient fulfills criteria for diagnosis of Anorexia Nervosa (of which there are two types: restricting or binge-eating/purging) or Eating Disorder Not Otherwise Specified, with a weight of less than or equal to 85% of his or her ideal body weight, as can best be determined at the time of assessment
  • Treated by physician on the eating disorder team at the Children's Hospital of Eastern Ontario (CHEO)

Exclusion Criteria:

  • Currently receiving treatment with any other antipsychotic medication, mood stabiliser, or stimulant
  • Known diagnosis of: diabetes, impaired glucose tolerance, hyperlipidemia, hepatic dysfunction, substance dependence, narrow angle glaucoma, paralytic ileus, or pancreatitis, or any other medical illness that would be considered to significantly impact treatment or recovery from the eating disorder
  • Any uncontrolled comorbid disease affecting any system including infectious, endocrine, renal, gastroenterologic, respiratory, cardiac, immunologic, or hematologic. Potential participants with controlled comorbidities in these areas may be invited to participate at the discretion of the primary investigator.
  • Experienced one or more seizures without clear and resolved etiology
  • Inability to comply with trial requirements including lack of comprehension of English
  • Pregnant or breast-feeding
  • High blood pressure
  • Known allergy or known sensitivity to products in olanzapine
  • Other unspecified reasons that, in the opinion of the investigator, amke the patient unsuitable for enrollment
  • Officially declared incapable of consenting to treatment under the Mental Health Act (Note: If a patient is involuntarily hospitalized, he or she can be invited to participate provided that he or she has not officially been deemed incapable of making treatment decision under the Mental Health Act)
  • Clinically judged to be at serious suicidal ris
  • More than 6 months have passed between the patient's initial eating disorder assessment and the time of study entry
  • Liver function test (ALT) > 1.5 x upper limit of normal (ULN)
  • Positive pregnancy test
  • Electrocardiogram (ECG): QTc > 450 msec or arrythmia other than sinus bradycardia; conduction abnormalities, prolonged QTc or other
  • LDL-C > 4.9 mmol/L
  • Total cholesterol/HDL ratio > 6
  • Fasting glucose > or equal to 6.1 mmol/L
  • Neutrophil count < 0.5 x 10^9/L
  • Prolactin level at assessment > 200 ng/mL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olanzapine
Those who choose to take olanzapine as part of their treatment (standard practice plus medication).
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.
Other Names:
  • Teva-Olanzapine
  • Dins: 02276712 and 02276720
No Intervention: Comparison
Those who choose not to take olanzapine as part of their treatment (standard practice).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Disorder Symptom Severity Scale
Time Frame: 12 weeks
Psychological Primary Outcome: The Eating Disorder Symptom Severity Scale is a clinician-rated measure of eating disorder severity, and behavioural and cognitive eating disorder symptoms.
12 weeks
Rate of weight gain
Time Frame: 12 weeks
Medical Primary Outcome: Rate of weight gain will be measured throughout the trial.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Depression Inventory
Time Frame: 12 weeks
Psychological measure that assesses cognitive, behavioural, and somatic symptoms of depression.
12 weeks
Multidimensional Anxiety Scale for Children
Time Frame: 12 weeks
Psychological measure that assesses anxiety.
12 weeks
Eating Disorder Examination Questionnaire-Adolescent
Time Frame: 12 weeks
Assesses behaviours and attitudes associated with eating disorders in youth 13 years of age and older.
12 weeks
The Children's Eating Attitudes Test
Time Frame: 12 weeks
Assesses behaviours and attitudes associated with eating disorders in youth between the ages of 8 and 12.
12 weeks
Child Behavior Checklist
Time Frame: 12 weeks
Evaluates parents' perceptions of their child's mood and anxiety
12 weeks
Eating Disorder Restlessness Agitation Drug Sleep Scale (for youth and parents)
Time Frame: 12 weeks
Thes questionnaire asks specific questions about restlessness, eating disorder cognitions, sleep, medication, and the patient's desire to recover from the eating disorder, that are not addressed in the other questionnaires.
12 weeks
Eating Disorder Inventory-3
Time Frame: 12 weeks
Psychological measure that assess psychological traits and symptoms relevant to the development and maintenance of eating disorders.
12 weeks
Overall Safety Profile
Time Frame: 12 weeks
An overall assessment of the safety profile of olanzapine will be done. This will include examination of reported adverse events, vital signs, electrocardiograms, urinalysis, and blood chemistry.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Eastern Ontario

Investigators

  • Principal Investigator: Wendy J Spettigue, MD, FRCPC, Children's Hospital of Eastern Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 13, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (Estimate)

August 19, 2010

Study Record Updates

Last Update Posted (Estimate)

September 4, 2014

Last Update Submitted That Met QC Criteria

September 3, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGDM24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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