Title: Treating Anxiety to PrevEnt Relapse in Schizophrenia (TAPERS) - a feasibility trial
Funder: Health and Care Research Wales (Welsh Government)

Abstract: AIM The aim of this proposal is to establish the feasibility and acceptability of the addition of antidepressant medication to antipsychotic treatment in patients with early psychosis to prevent relapse. This trial will also seek to optimise the intervention through the embedded process evaluation. By the end of the trial we will be in a position to proceed to a fully powered effectiveness trial of add-on antidepressant treatment in early psychosis, with the potential for major health benefits and cost savings to the NHS. BACKGROUND Psychotic illnesses including schizophrenia are highly disabling mental disorders which affect c.3% of the population at a cost to the UK economy more than £11 Bn per year (www.schizophreniacommission.org.uk/the-report/). Anxiety and affective symptoms are a prominent feature of schizophrenia and related psychotic disorders and often precede psychotic relapses. A number of studies suggest that genetic risk for the disorder may be associated with increased anxiety before the onset of psychotic symptoms, suggesting that increased anxiety may be causally related to the development of psychosis. Targeting anxiety symptoms may thus represent an important novel strategy for the primary and secondary prevention of psychosis. There is substantial meta-analytic evidence that antidepressants, which decrease anxiety, are well-tolerated in psychotic illnesses such as schizophrenia. However no trials we are aware of, have directly investigated whether antidepressant treatment in individuals in the early stages of a psychotic illness decreases subsequent relapse rates. The issues associated with conducting a full scale RCT will be addressed in this feasibility trial. PLAN OF INVESTIGATION In this pragmatic randomised controlled feasibility trial, we will recruit 40 individuals with early psychosis (within 3 years of initial treatment), not currently prescribed an antidepressant, from psychosis services across two Welsh health boards. They will be randomised to receive either add-on antidepressant medication (citalopram 20mg - chosen for its efficacy, safety and simple dosing) or placebo in addition to treatment as usual over a 24 week period. Measures of psychotic symptoms and anxiety / affective symptoms will be taken at 4 weeks and 24 weeks. Blood levels of antidepressant and antipsychotic medications will be taken at week 4 to establish adherence. As part of our broader process evaluation, we will conduct in-depth interviews with 20 patients and their carers, to explore attitudes to the add-on treatment and experiences on the medication. We will also explore the impact of wider contextual factors on trial recruitment, delivery, uptake and adherence. At the end of the 24 week trial period patients will be unblinded and offered open label continuation of the treatment if considered effective in consultation with their consultant. BENEFITS Psychotic illnesses place an enormous burden on the NHS, sufferers and carers. Relapses of psychotic illness are associated with significant functional impairment and poor quality of life. This trial will establish whether the addition of antidepressant medication to standard antipsychotic medication is an acceptable and feasible approach to decrease relapse rates in psychosis and will pave the way to a large-scale trial of this intervention. If successful, any intervention decreasing relapse rates in psychosis would have major benefits for the NHS.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: MENTAL HEALTH