ISRCTN80075010进行中（未招募）未知
Olanzapine for young PEople with aNorexia nervosa (OPEN): an open-label feasibility study to test recruitment, treatment acceptance, adherence, safety, and outcome measures assessment and patients' experience to prepare for a definitive randomised placebo-controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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