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

Primary Purpose

Eating Disorder

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder focused on measuring Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Olanzapine, Pediatric

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Olanzapine

Comparison

Arm Description

Those who choose to take olanzapine as part of their treatment (standard practice plus medication).

Those who choose not to take olanzapine as part of their treatment (standard practice).

Outcomes

Primary Outcome Measures

Eating Disorder Symptom Severity Scale
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.
Rate of weight gain
Medical Primary Outcome: Rate of weight gain will be measured throughout the trial.

Secondary Outcome Measures

Children's Depression Inventory
Psychological measure that assesses cognitive, behavioural, and somatic symptoms of depression.
Multidimensional Anxiety Scale for Children
Psychological measure that assesses anxiety.
Eating Disorder Examination Questionnaire-Adolescent
Assesses behaviours and attitudes associated with eating disorders in youth 13 years of age and older.
The Children's Eating Attitudes Test
Assesses behaviours and attitudes associated with eating disorders in youth between the ages of 8 and 12.
Child Behavior Checklist
Evaluates parents' perceptions of their child's mood and anxiety
Eating Disorder Restlessness Agitation Drug Sleep Scale (for youth and parents)
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.
Eating Disorder Inventory-3
Psychological measure that assess psychological traits and symptoms relevant to the development and maintenance of eating disorders.
Overall Safety Profile
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.

Full Information

First Posted
August 13, 2010
Last Updated
September 3, 2014
Sponsor
Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT01184443
Brief Title
Evaluation of the Efficacy and Safety of Olanzapine for Anorexia Nervosa in Children and Adolescents
Official Title
Evaluation of the Efficacy and Safety of Olanzapine as an Adjunctive Treatment for Anorexia Nervosa in Children and Adolescents: An Open-label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder
Keywords
Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Olanzapine, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
Those who choose to take olanzapine as part of their treatment (standard practice plus medication).
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
Those who choose not to take olanzapine as part of their treatment (standard practice).
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Teva-Olanzapine, Dins: 02276712 and 02276720
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eating Disorder Symptom Severity Scale
Description
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.
Time Frame
12 weeks
Title
Rate of weight gain
Description
Medical Primary Outcome: Rate of weight gain will be measured throughout the trial.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Children's Depression Inventory
Description
Psychological measure that assesses cognitive, behavioural, and somatic symptoms of depression.
Time Frame
12 weeks
Title
Multidimensional Anxiety Scale for Children
Description
Psychological measure that assesses anxiety.
Time Frame
12 weeks
Title
Eating Disorder Examination Questionnaire-Adolescent
Description
Assesses behaviours and attitudes associated with eating disorders in youth 13 years of age and older.
Time Frame
12 weeks
Title
The Children's Eating Attitudes Test
Description
Assesses behaviours and attitudes associated with eating disorders in youth between the ages of 8 and 12.
Time Frame
12 weeks
Title
Child Behavior Checklist
Description
Evaluates parents' perceptions of their child's mood and anxiety
Time Frame
12 weeks
Title
Eating Disorder Restlessness Agitation Drug Sleep Scale (for youth and parents)
Description
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.
Time Frame
12 weeks
Title
Eating Disorder Inventory-3
Description
Psychological measure that assess psychological traits and symptoms relevant to the development and maintenance of eating disorders.
Time Frame
12 weeks
Title
Overall Safety Profile
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy J Spettigue, MD, FRCPC
Organizational Affiliation
Children's Hospital of Eastern Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30038658
Citation
Spettigue W, Norris ML, Maras D, Obeid N, Feder S, Harrison ME, Gomez R, Fu MC, Henderson K, Buchholz A. Evaluation of the Effectiveness and Safety of Olanzapine as an Adjunctive Treatment for Anorexia Nervosa in Adolescents: An Open-Label Trial. J Can Acad Child Adolesc Psychiatry. 2018 Aug;27(3):197-208. Epub 2018 Jul 1.
Results Reference
derived

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

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