A randomised controlled trial of antipsychotic medication in comparison to psychological intervention and a combined treatment in children and young people with first episode psychosis: a feasibility study

Greater Manchester West Mental Health NHS Foundation Trust0 个研究点目标入组 61 人开始时间: 2017年2月27日最近更新: 2021年2月8日

试验速览

•1. Aged 14-18 (to ensure adolescent status)
•2. In contact with Early Intervention Services/Child and Adolescent Mental Health Services (to ensure appropriate safety considerations can be implemented)
•3. Competent to provide written, informed consent, with additional parental consent for those aged < 16 (for ethical considerations).
•4. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) to allow for diagnostic uncertainty in early phases of psychosis
•5. Within 1 year of onset of psychosis (to ensure first episode status)
•6. Score 4+ on Positive and Negative Syndrome Scale (PANSS) delusions or hallucinations [for a minimum duration of seven consecutive days] (to ensure current psychosis)
•7. Help-seeking (for ethical considerations)

•1. A primary diagnosis of alcohol/substance dependence *
•2. A diagnosis of moderate or severe learning disability *
•3. A diagnosis of ICD-10 organic psychosis *
•4. Score 5+ on PANSS conceptual disorganisation / disorganised speech (since majority of participants will be randomised to a talking therapy, we require capacity to answer questions in an interview situation and engage in a conversation)
•5. Non-English speaking (since majority of participants will be randomised to a talking therapy)
•6. Received APs or structured PI within the last 3 months (to ensure treatment naivety)
•7. Immediate risk to self or others (to ensure appropriate safety considerations can be addressed)
•* These exclusions are to ensure that the participant population are representative of young people with a primary problem of first episode psychosis

发起方

Greater Manchester West Mental Health NHS Foundation Trust