Eating DisorderPhase 3NCT01184443
Evaluation of the Efficacy and Safety of Olanzapine for Anorexia Nervosa in Children and Adolescents
A Phase 3 study testing Olanzapine in people with Eating Disorder, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Olanzapine
- Keywords
- Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Olanzapine, Pediatric
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Teva-Olanzapine, Dins: 02276712 and 02276720
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.
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | Those who choose to take olanzapine as part of their treatment (standard practice plus medication). Receives: Drug: Olanzapine |
| Comparison | No intervention | Those who choose not to take olanzapine as part of their treatment (standard practice). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Rate of weight gain
Medical Primary Outcome: Rate of weight gain will be measured throughout the trial.
Measured: 12 weeks
Secondary outcomes (8)
Children's Depression Inventory
Psychological measure that assesses cognitive, behavioural, and somatic symptoms of depression.
Measured: 12 weeks
Multidimensional Anxiety Scale for Children
Psychological measure that assesses anxiety.
Measured: 12 weeks
Eating Disorder Examination Questionnaire-Adolescent
Assesses behaviours and attitudes associated with eating disorders in youth 13 years of age and older.
Measured: 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.
Measured: 12 weeks
Child Behavior Checklist
Evaluates parents' perceptions of their child's mood and anxiety
Measured: 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.
Measured: 12 weeks
Eating Disorder Inventory-3
Psychological measure that assess psychological traits and symptoms relevant to the development and maintenance of eating disorders.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionMar 2014
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Spettigue, Children's Hospital of Eastern Ontario
- Investigators
- Wendy J Spettigue, MD, FRCPC, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184443
- Sponsor's protocol ID
- RGDM24
- Status last verified
- Sep 2014
- First submitted
- 13 Aug 2010
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30038658
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01184443
- Acronym / sponsor ID
- RGDM24
- Conditions
- Eating Disorder
- Keywords
- Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Olanzapine, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: OlanzapineThose who choose to take olanzapine as part of their treatment (standard practice plus medication). |
| Comparison | No intervention | –Those who choose not to take olanzapine as part of their treatment (standard practice). |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlanzapineAlso: Teva-Olanzapine, Dins: 02276712 and 02276720Dosing 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. | Drug | Olanzapine |
Primary outcome
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.
Rate of weight gain
Time frame: 12 weeks
Medical Primary Outcome: Rate of weight gain will be measured throughout the trial.
8 secondary outcomes
Children's Depression Inventory
Time frame: 12 weeks
Multidimensional Anxiety Scale for Children
Time frame: 12 weeks
Eating Disorder Examination Questionnaire-Adolescent
Time frame: 12 weeks
The Children's Eating Attitudes Test
Time frame: 12 weeks
Child Behavior Checklist
Time frame: 12 weeks
Eating Disorder Restlessness Agitation Drug Sleep Scale (for youth and parents)
Time frame: 12 weeks
Eating Disorder Inventory-3
Time frame: 12 weeks
Overall Safety Profile
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
- Derived from this study: PubMed 30038658Spettigue 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy J Spettigue, MD, FRCPC principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine in people with Eating Disorder, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Symptom Severity Scale (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01184443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2014.