Condition category
Mental and Behavioural Disorders
Date applied
04/04/2018
Date assigned
20/04/2018
Last edited
20/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
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. The aim of this 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.

Who can participate?
Patients aged 18 or over with schizophrenia and related psychosis

What does the study involve?
Participants are randomly allocated to either switch (change antipsychotic) or no-switch (continue on current antipsychotic). Those allocated to switch are prescribed one of a choice of three antipsychotics. In addition, all study participants receive two sessions of advice and support delivered by a trained doctor or nurse to address sexual problems. Patients are followed up for 6 months to measure sexual dysfunction.

What are the possible benefits and risks of participating?
It is possible that sexual problems will improve in some of the participants in the study. The information from this study should improve understanding of sexual problems associated with antipsychotic medication. It is not anticipated that participants will have a negative response to the advice and support sessions. Participants allocated to the switch group may experience side effects changing to a new antipsychotic medication.

Where is the study run from?
1. Central and North West London NHS Foundation Trust (UK)
2. Leeds and Yorkshire Partnership NHS Foundation Trust (UK)
3. Northumberland Tyne and Wear NHS Foundation Trust (UK)
4. South West Yorkshire Partnership NHS Foundation Trust (UK)
5. Tees Esk and Wear NHS Foundation Trust (UK)
6. West London NHS Mental Health Trust (UK)

When is the study starting and how long is it expected to run for?
May 2018 to October 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Amy Claringbold
a.claringbold@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Amy Claringbold

ORCID ID

Contact details

Imperial College London
7th Floor Commonwealth Building
Du Cane Road
London
W12 0NN
United Kingdom
+44 (0)2083834134
a.claringbold@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37678

Study information

Scientific title

Management of sexual dysfunction associated with antipsychotic drugs

Acronym

REMEDY

Study hypothesis

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.

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.

Ethics approval

West Midlands Solihull Research Ethics Committee, REC ref: 18/WM/0076 - approval pending

Study design

Randomised; Interventional; Design type: Treatment, Drug, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Mental health, Primary sub-specialty: Psychosis - schizophrenia; UKCRC code/ Disease: Mental Health/ Schizophrenia, schizotypal and delusional disorders

Intervention

Participants will be randomised on a 1:1 allocation ratio using a remote web-based randomisation system to either enhanced standard care plus a switch in antipsychotic medication or enhanced standard care alone.

Enhanced standard care
All study participants will be offered two sessions of enhanced standard care comprising usual treatment plus brief advice and support to discuss their sexual health and functioning.

Antipsychotic switch
In addition to enhanced standard care, those in the “switch” arm of the trial will be offered a change in their current antipsychotic medication to a choice of three antipsychotics with a lower tendency to cause sexual dysfunction: aripiprazole, quetiapine and olanzapine.

Patients will be recruited from NHS community mental health services and followed up for 6 months.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Patient reported sexual dysfunction measured using the Arizona Sexual Experience scale (ASEX) at baseline, 3 and 6 months. Primary outcome at 6 months.

Secondary outcome measures

1. Sexual behaviour measured using questions from the National Survey of Sexual Attitudes and Lifestyles (NATSAL) at baseline and 6 months
2. Researcher-rated sexual functioning measured using the Clinical Global Impression for Sexual Functioning at 6 months
3. Mental health measured using the total score on the Positive and Negative Syndrome Scale (PANSS) at baseline and 6 months
4. Side effects of medication measured using the Antipsychotic Non-Neurological Side Effects Scale (ANNSERS) at baseline and 6 months
5. Medication adherence measured using the Brief Adherence Rating Scale (BARS) at baseline and 6 months
6. Quality of life measured using the European Quality of Life-5 Dimensions (EQ-5D-5L) 40 and the Recovering Quality of Life (REQOL) questionnaire at baseline and 6 months
7. Resource use measured using the Adult Service Use Schedule (AD-SUS) at baseline and 6 months

Overall trial start date

01/05/2018

Overall trial end date

31/10/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Men or women aged 18 or over
2. A clinical diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis not otherwise specified, as defined by DSM-IV
3. Sexual dysfunction associated with antipsychotic medication for whom reducing the dose of their current antipsychotic was either not effective or not appropriate
4. Assessed by their clinical team as not having an underlying physical condition that is responsible for their sexual dysfunction

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 232; UK Sample Size: 232

Participant exclusion criteria

1. Acutely psychotic or have been so within the last 3 months
2. Unable to speak sufficient English to complete the baseline assessment
3. Currently prescribed clozapine as this medication is restricted to those with treatment resistant psychosis
4. Current sexual problems started prior to their taking antipsychotic medication
5. Currently taking part in another clinical trial

Recruitment start date

01/08/2018

Recruitment end date

30/04/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central and North West London NHS Foundation Trust (lead centre)
15-21 Headstone Drive
Harrow
HA3 5QX

Trial participating centre

Leeds and Yorkshire Partnership NHS Foundation Trust
2150, Thorpe Park
Leeds
LS15 8ZB

Trial participating centre

Northumberland Tyne and Wear NHS Foundation Trust
Wolfson Research Centre Institute of Neuroscience Campus for Ageing and Vitality Westgate Road
Newcastle Upon Tyne
NE4 5PL

Trial participating centre

South West Yorkshire Partnership NHS Foundation Trust
Fieldhead Ouchithorpe Lane
Wakefield
WF1 3SP

Trial participating centre

Tees Esk and Wear NHS Foundation Trust
Flatts Lane Centre Normanby Road
TS6 0SZ

Trial participating centre

West London NHS Mental Health Trust
Clinical Trials Facility Lakeside Mental Health Unit West Middlesex University Hospital Site Twickenham Road
Isleworth
TW7 6AF

Sponsor information

Organisation

Imperial College Healthcare NHS Trust

Sponsor details

St Mary's Hospital
Praed Street
Paddington
London
W2 1NY
United Kingdom
+44 (0)207 594 9459
becky.ward@imperial.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/95/01

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists will publish their results in the Health Technology Assessment Journal (March 2021) and widely read high-quality peer-reviewed open access journals. The results of the study will be presented at leading conferences for psychiatrists and mental health pharmacists. In addition, should the intervention demonstrate benefit for patients they will host an interactive free-to-access webinar on managing sexual dysfunction associated with use of antipsychotic medication for people with schizophrenia and related psychoses.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes