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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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.
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
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.
Time frame: 12 weeks
Rate of weight gain
Medical Primary Outcome: Rate of weight gain will be measured throughout the trial.
Time frame: 12 weeks
Children's Depression Inventory
Psychological measure that assesses cognitive, behavioural, and somatic symptoms of depression.
Time frame: 12 weeks
Multidimensional Anxiety Scale for Children
Psychological measure that assesses anxiety.
Time frame: 12 weeks
Eating Disorder Examination Questionnaire-Adolescent
Assesses behaviours and attitudes associated with eating disorders in youth 13 years of age and older.
Time frame: 12 weeks
The Children's Eating Attitudes Test
Assesses behaviours and attitudes associated with eating disorders in youth between the ages of 8 and 12.
Time frame: 12 weeks
Child Behavior Checklist
Evaluates parents' perceptions of their child's mood and anxiety
Time frame: 12 weeks
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.
Time frame: 12 weeks
Eating Disorder Inventory-3
Psychological measure that assess psychological traits and symptoms relevant to the development and maintenance of eating disorders.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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