REMEDY: Assessing approaches aimed at improving sexual functioning
Research type
Research Study
Full title
Management of sexual dysfunction associated with antipsychotic drugs
IRAS ID
236872
Contact name
Mike Crawford
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
12307891
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
The aim of the study is to investigate whether, among people with schizophrenia and related psychoses who experience sexual dysfunction associated with the use of antipsychotic medication, if switching their antipsychotic medication to one with a lower reported association with sexual side effects improves sexual functioning.
Two hundred and sixteen adults with schizophrenia and related psychosis will be randomised in equal numbers to either switch (changing antipsychotic) or no-switch (continue on current antipsychotic). Those allocated to switch will be prescribed one of a choice of three antipsychotics. In addition, all study participants will receive two sessions of advice and support delivered by a trained doctor or nurse to address sexual problems. Patients will be recruited from NHS community mental health services and followed up for 6 months.
Schizophrenia is a severe mental health condition that affects almost a quarter of a million people in the UK. The illness usually starts in early adult life and can have a major impact on a person’s quality of life and social functioning. Antipsychotic medication provides effective treatment for most people with the condition, but these drugs have a range of side effects which can impair a person’s quality of life. At least half of people who take antipsychotic medication for schizophrenia experience sexual dysfunction. Sexual dysfunction may have a considerable impact on a person’s quality of life, particularly for people with psychosis who are more likely to experience relationship problems and social isolation resulting from poor mental health and stigmatisation. Previous studies of switching a person’s antipsychotic medication have demonstrated beneficial effects. However, there is uncertainty about how effective switching antipsychotic medication is. This study will provide clinicians and patients with the evidence they need to know whether to use this approach to manage sexual dysfunction associated with use of antipsychotic drugs.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
18/WM/0076
Date of REC Opinion
21 Apr 2018
REC opinion
Further Information Favourable Opinion