Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Victoria, Australia.
Centre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, Australia.
Early Interv Psychiatry. 2019 Dec;13(6):1345-1356. doi: 10.1111/eip.12769. Epub 2018 Nov 29.
Antipsychotic medication has been the mainstay of treatment for psychotic illnesses for over 60 years. This has been associated with improvements in positive psychotic symptoms and a reduction in relapse rates. However, there has been little improvement in functional outcomes for people with psychosis. At the same time there is increasing evidence that medications contribute to life shortening metabolic and cardiovascular illnesses. There is also uncertainty as to the role played by antipsychotic medication in brain volume changes.
The primary aim of the study is, in a population of young people with first-episode psychosis, to compare functional outcomes between an antipsychotic dose reduction strategy with evidence-based intensive recovery treatment (EBIRT) group (DRS+) and an antipsychotic maintenance treatment with EBIRT group (AMTx+) at 24-months follow-up.
Our single-blind randomized controlled trial, within a specialist early psychosis treatment setting, will test the whether the DRS+ group leads to better vocational and social recovery than, the AMTx+ group over a 2-year period in 180 remitted first-episode psychosis patients. Additionally, we will examine the effect of DRS+ vs AMTx+ on physical health, brain volume and cognitive functioning. This study will also determine whether the group receiving DRS+ will be no worse off in terms of psychotic relapses over 2 years follow-up.
This paper presents the protocol, rationale and hypotheses for this study which commenced recruitment in July 2017.
This study will provide evidence as to whether an antipsychotic dose-reduction recovery treatment leads to improved functioning and safer outcomes in first-episode psychosis patients. In addition, it will be the first-controlled experiment of the effect of exposure to antipsychotic maintenance treatment on brain volume changes in this population.
抗精神病药物作为治疗精神疾病的主要手段已经超过 60 年了。这与改善阳性精神病症状和降低复发率有关。然而，精神疾病患者的功能预后改善甚微。与此同时，越来越多的证据表明药物会导致代谢和心血管疾病的寿命缩短。抗精神病药物在脑容量变化中的作用也存在不确定性。
本研究的主要目的是，在首发精神分裂症的年轻人群中，比较抗精神病药物剂量减少策略与基于证据的强化康复治疗（DRS+）组和抗精神病药物维持治疗与基于证据的强化康复治疗（AMTx+）组在 24 个月随访时的功能预后。
我们的单盲随机对照试验，在专门的早期精神病治疗环境中，将测试在 2 年的时间里，DRS+组是否比 AMTx+组在职业和社会康复方面表现更好，纳入 180 名缓解的首发精神分裂症患者。此外，我们将检查 DRS+对身体健康、脑容量和认知功能的影响。本研究还将确定在 2 年的随访中，接受 DRS+的患者在精神病复发方面是否不会更糟。
本文介绍了该研究的方案、原理和假设，该研究于 2017 年 7 月开始招募。
这项研究将提供证据，证明抗精神病药物剂量减少恢复治疗是否能改善首发精神分裂症患者的功能和更安全的结果。此外，这将是首次在该人群中对照实验抗精神病药物维持治疗对脑容量变化的影响。
