Evaluation of the Efficacy and Safety of Olanzapine for Anorexia Nervosa in Children and Adolescents
Status:
Terminated
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
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.