Title: REMEDY: Randomised Evaluation of Management of sExual DYsfunction
Funder: Department of Health and Social Care

Abstract: Design: A two-arm, parallel-group, researcher-blind, RCT with an internal pilot and parallel process evaluation. Study groups are: enhanced standard care plus switch of antipsychotic drug and enhanced standard care alone. Setting: NHS community mental health services. Target population: People aged 18 years or over, with a clinical diagnosis of schizophrenia or related psychoses who have sexual dysfunction associated with the use of antipsychotic medication, for whom reducing the dose of their medication is ineffective or inappropriate. Exclusion criteria: People will be excluded if: acutely unwell; they have had a change in antipsychotic medication in the last six weeks; currently prescribed clozapine; their sexual dysfunction preceded their use of antipsychotic medication; they have an untreated physical, mental or psychosexual disorder which underlies their sexual dysfunction. Health technologies being assessed: Switching to an equivalent dose of one of three antipsychotic drugs that have a lower liability for sexual side effects (quetiapine, aripiprazole or olanzapine). All participants will also be offered brief psychoeducation and support to discuss their sexual health and functioning. Measurement of costs and outcomes: The primary outcome is patient-reported sexual dysfunction, measured using the Arizona Sexual Experience scale (ASEX). Secondary outcomes are researcher-rated sexual functioning (CGI for Sexual Functioning), mental health (PANSS); adherence to and side effects of medication; health-related quality of life (EQ-5D-5L and Reqol); and service utilisation (AD-SUS). All measures will be assessed at baseline and six months. Sexual function and adverse effects will also be assessed at three months. Baseline serum prolactin level and use of alcohol and drugs will also be collected. Qualitative interviews will be conducted with a purposive sample of participants and clinicians to explore the relationship between interventions received, trial processes and study outcomes. Sample size: A total sample of 216 participants is required to have 90% power to detect three-point differences (SD = 6.0) between the mean score on the ASEX at a 5% significance level, based on a dropout rate of 20% at six months. Difference between current and planned care pathways: All patients prescribed antipsychotic medication should be assessed for side effects but in practice assessment of sexual dysfunction is often missed. When patients complain of sexual dysfunction and clinician’s judge it is related to antipsychotic medication they may reduce the dose or switch to an alternative drug. In this trial we will work with clinicians and patients to improve the implementation of recommendations for screening side effects of medication and offer participation in the trial to those reporting sexual dysfunction associated with antipsychotic medication. Project timetables: 33 months in total. Start of recruitment 01.08.18. Rate of recruitment 3 per centre per month. Pilot phase at 2 centres for six months, followed by further 15 months recruitment. Three months for write up and reporting. Expertise in team: We are a multidisciplinary team of service users, providers and researchers, including; statistician, health economist, trialists, mental health nursing, pharmacist, psychiatrist, psychologist and a service user representative.

Lay abstract: Schizophrenia and related psychoses affect over 250,000 people in Britain. A number of drugs improve the mental health of people with psychosis; these are called ‘antipsychotic’ drugs. Most people who take antipsychotic drugs get side effects. Up to a half of people who take them experience sexual side effects including reduced desire for sex and less pleasure from having sex. These side effects impair people’s quality of life and can lead some to stop taking their medication. This increases the chances of a person relapsing and being admitted to hospital. Sexual side effects are those least likely to be assessed by doctors and nurses. One of the reasons for this is that staff are unsure what to do if they find out that people have these problems. A recent review of studies in this area highlighted how switching between different antipsychotic drugs may help. But previous studies were too small and too short to be sure that it is a safe approach that offers lasting benefit to patients. We are a team of providers and users of health services who have designed a study which we believe will provide the information people need to help tackle this important problem. Our team includes experts in statistics, health economics, psychology, mental health pharmacy, nursing and psychiatry. We plan to conduct a large-scale study to compare the effects of switching a person’s medication to an equivalent dose of an alternative antipsychotic drug that is believed to result in fewer sexual side effects. Each person that takes part in the study will have an equal chance of receiving a switch in their medication or no switch. They will all also receive brief advice on sexual health and sexual functioning. We will recruit people aged 18 years or over who have psychosis and suffer from sexual dysfunction associated with taking antipsychotic drugs. We will not recruit people if they are acutely unwell, if their current sexual dysfunction preceded their use of antipsychotic drugs, if they have had a change in antipsychotic medication in the last six weeks or if they have an untreated physical or mental health condition which seems to be causing their sexual problems. We will recruit people from NHS community mental health services in four different areas of the country that have a successful track record of conducting clinical trials among people with schizophrenia. At the start of the study we will assess patients’ experience of their sexual functioning together with researcher-rated sexual functioning, side effects of medication, mental health, health-related quality of life, and use of healthcare and other services. We will follow people up three months and six months after they enter the study to find out if switching medication is effective. We will take steps to ensure that researchers conducting follow-up assessments do not know whether the patient’s medication was changed. We will also conduct qualitative interviews with people who take part in the study. If the intervention is successful we will use this information to ensure these interventions are delivered more widely to all those who need them. We believe that this study can help make sure that patients who experience these problems get an effective response to them and that clinicians have the information they need to help people who experience sexual problems that are associated with the use of antipsychotic drugs.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: MENTAL HEALTH