Anorexia nervosa (AN) Mental and Behavioural Disorders Anorexia nervosa
Conditions
Interventions
This is a one-arm open treatment design, there is no placebo and no comparator. The initial olanzapine dosage will start at 1.25 mg/day or 2.5 mg/day in adolescent patients and continue this dose or i
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adolescent or young adults (12-24 years old) 2. Receiving inpatient, day care or outpatient treatment 3. Diagnosed with AN, or atypical AN, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) 4. Patients have gained <2 kg within at least 1 month of TAU. Outpatients should have attended =4 therapeutic sessions. 2 kg within the time frame of at least 1 month appears most appropriate to predict further therapy response or non-response to the current treatment according to our systematic review and meta-analysis on early response and treatment outcome prediction 5. The patient can read and write in English 6. Written informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Serious self-harm, suicidality, psychotic disorder, serious medical comorbidities (as detailed below) which are contraindications for olanzapine 2. Current alcohol or illicit drug use disorder 3. On major tranquilliser or opioids 4. QTc interval >450 ms (two separate ECG measurements) 5. A QTc interval >500 ms in the ECG or rises by more than 60 msec from baseline or other severe cardiac side effects will stop study participation of this patient 6. A QTc interval >500 ms in the ECG or rises by more than 60 msec from baseline or other severe cardiac side effects in more than one patient in the feasibility study will lead to a stop of the study 7. Alerting liver function tests or white cell count 7.1. Bilirubin >40 7.2. Alkpase >200 7.3. AsT >80 7.4. ALT >90 7.5. GGT >90 8. On other medication at stable dose for <4 weeks 9. On medication interacting with olanzapine 10. Pregnancy 11. No willingness to pregnancy test (females of childbearing potential) 12. No willingness to take effective contraceptive measures as specified under section 8.10. on trial restrictions. The participant information and consent sheet include a section on pregnancy and appropriate birth control measures (females of childbearing potential). 13. Breastfeeding 14. Insufficient understanding of the trial/lack of capacity to agree to the trial procedures as assessed by the responsible clinician 15. Hypersensitivity to olanzapine or to any of its excipients 16. Taking part in another pharmacological trial for AN 17. Involvement in research that includes contraindications for treatment with olanzapine Serious self-harm means one of the following: 1. Recent (within the last 12 months) self-harm with suicidal intent 2. Recent self-harm with the risk to a person’s own life (e.g., drug intake, deep cutting, burning, swallowing sharp items) 3. Recent self-harm which could lead, or has led, to long-lasting impairment of one’s health and functioning Serious medical comorbidities which are contraindications for olanzapine mean one of the following: 1. Coronary heart disease 2. Cerebrovascular disease 3. Parkinson’s disease, parkinsonism or dementia 4. Hepatic or renal impairment The researchers will examine and document all physical and mental comorbidities that are not exclusion criteria. For example, mood disorders, obsessive-compulsive disorder, anxiety disorders and personality disorders are common co-morbidities which are not exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of carrying out such a trial to inform a future definitive RCT, assessed using: 1. The proportion of patients in different settings (adolescent/adult, inpatient/daycare/ outpatient) who 1.1. Agree to take olanzapine (un-blinded, real-life conditions) at baseline 1.2. Adhere to olanzapine at week 8, week 16, 6 months, 12 months 1.3. Complete all study assessments and questionnaires at baseline, week 8, week 16, 6 months, 12 months 2. The quality of reporting of adverse events at baseline, week 8, week 16, 6 months, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The feasibility of data collection procedures for the following measures: 1. Demographics, smoking, alcohol, and substance abuse measured using interviews and ASSIST questionnaires at baseline 2. Body weight and BMI measured using the formula BMI = kg/m² at baseline, week 8, week 16, 6 months, 12 months 3. Eating disorder psychopathology measured using EDE-Q, BAVQ-R, SREBQ questionnaires at baseline, week 8, week 16, 6 months, 12 months 4. General psychopathology measured using DASS/RCADS, Y-BOCS/CY-BOCS, C-SSRS questionnaires at baseline, week 8, week 16, 6 months, 12 months 5. Health economic and quality of life measured using ESS/ESS-CHAD questionnaire at baseline, week 8, week 16, 6 months, 12 months, and EQ-5D, CAA-SUS, EDSIS questionnaires at baseline, 6 months and 12 months 6. Drug adherence measured using questionnaire, pill count at 6 weeks, 16 weeks, 6 months, 12 months, olanzapine plasma level at 8 weeks 7. Drug safety measured using adverse events at baseline, week 8, week 16, 6 months, 12 months 8. Qualitative methods will be used to explore attitudes around willingness or refusal to participate in this feasibility and a potential blinded, placebo-controlled RCT through qualitative interviews at baseline and 16 weeks for those who agree to take part in the trial and at baseline for those who decline | — |
Countries
Australia, England, United Kingdom
Outcome results
None listed