Olanzapine for young people with anorexia nervosa

Not Applicable

• Conditions: Anorexia nervosa (AN); Mental and Behavioural Disorders; Anorexia nervosa

• Registration Number: ISRCTN80075010
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-27
• Last Update Posted: 13 November 2023
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 55

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified