Research into Antipsychotic Discontinuation And Reduction (RADAR)

The problem: Despite modern drug treatment, schizophrenia continues to be a debilitating and costly condition. Many people remain functionally impaired, and suffer substantial physical and mental side-effects from antipsychotic medication. Subsequently, people with schizophrenia are often unhappy with long-term antipsychotic use and tend to have poor adherence. Yet, there is little evidence to inform patients and clinicians in their difficult decision as to whether to continue with long-term antipsychotic medication or try and discontinue. Moreover, there are no guidelines for how to reduce and discontinue antipsychotics, if this is what patients want to do. The inadequacy of research on long-term treatment options for people with schizophrenia has been highlighted by the National Institute for Health and Care Excellence (NICE). Background: Continuous antipsychotic medication is the standard treatment for people with recurrent schizophrenia, but the evidence base has limitations. Notably trials have been mostly short-term, involved abrupt discontinuation of medication, and focused on relapse rather than social functioning as the main outcome. A recent seven year follow-up of a gradual antipsychotic discontinuation programme in people with first episode psychosis conducted in the Netherlands found that those in the discontinuation group had substantially better rates of social recovery, whilst relapses equalled out over time. Meta-analyses suggest antipsychotic discontinuation has similar effects in those with longer term conditions. Aims and Objectives: The overall aim of the research programme is to provide evidence on the outcomes of a supported antipsychotic reduction and discontinuation programme. The specific objectives are:1) to develop a protocol for a gradual and supported strategy of antipsychotic reduction and discontinuation2) to design a trial to evaluate this strategy in people with recurrent schizophrenia or related conditions3) to assess and pilot recruitment techniques for the planned trial in order to maximise and facilitate recruitment4) to compare the supported strategy of antipsychotic reduction and discontinuation with maintenance antipsychotic treatment in an internal pilot trial5) to conduct a full, randomised, multi-centre, pragmatic trial with social functioning as the primary outcome and relapse, symptoms, side effects and costs among further outcomes. Research Methods The research programme starts with development and feasibility work which will inform the design and conduct of the trial (WP 1). A methodology group will develop the intervention protocols in an iterative process. The interventions will consist of a flexible and gradual antipsychotic reduction and discontinuation strategy (ADRS), leading to discontinuation where feasible, and maintenance treatment (MT). Monitoring arrangements will be specified to facilitate early intervention if symptoms increase during the course of the trial, and measures for maintaining and assessing adherence to the intervention protocols will be designed. The methodology group will develop aspects of trial design, including new and valid criteria for relapse, since there is no widely-accepted, rigorous definition at present. The group will also formulate precise inclusion and exclusion criteria, considering duration of illness and treatment, risks, ongoing symptoms and substance misuse. A recruitment survey will be conducted to inform the recruitment strategy for the trial. An internal pilot will assess recruitment rates, intervention adherence, assessments and retention up to six months (WP 2). A full randomised controlled trial (RCT) will compare the antipsychotic reduction and discontinuation strategy (ADRS) with maintenance treatment (MT) (WP 3). Both the antipsychotic reduction and discontinuation strategy (ADRS) and maintenance treatment (MT) will be supervised by the participant s usual psychiatrist, with training and support from the researc