Assessing approaches aimed at improving sexual functioning
| ISRCTN | ISRCTN12307891 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12307891 |
| Protocol serial number | 37678 |
| Sponsor | Imperial College Healthcare NHS Trust |
| Funder | NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/95/01 |
- Submission date
- 04/04/2018
- Registration date
- 20/04/2018
- Last edited
- 12/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Other
Plain English summary of protocol
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?
Dr Verity Leeson
v.leeson@imperial.ac.uk
Contact information
Scientific
Imperial College London
7th Floor Commonwealth Building
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 (0)2083834134 |
|---|---|
| v.leeson@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment, Drug, Psychological & Behavioural |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Management of sexual dysfunction associated with antipsychotic drugs |
| Study acronym | REMEDY |
| Study objectives | 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(s) | Approved 05/08/2018, West Midlands Solihull Research Ethics Committee (The Old Chapel Royal Standard Place, Nottingham, NG1 6FS; +442071048104; NRESCommittee.WestMidlands-Solihull@nhs.net), ref: 18/WM/0076 |
| Health condition(s) or problem(s) studied | Antipsychotic-Induced Sexual Dysfunction |
| 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 |
| Primary outcome measure(s) |
Patient reported sexual dysfunction measured using the Arizona Sexual Experience scale (ASEX) at baseline, 3 and 6 months. Primary outcome at 6 months. |
| Key secondary outcome measure(s) |
1. Sexual behaviour measured using questions from the National Survey of Sexual Attitudes and Lifestyles (NATSAL) at baseline and 6 months |
| Completion date | 31/10/2021 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 232 |
| Total final enrolment | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 30/04/2020 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Harrow
HA3 5QX
United Kingdom
Leeds
LS15 8ZB
United Kingdom
Institute of Neuroscience
Campus for Ageing and Vitality
Westgate Road
Newcastle Upon Tyne
NE4 5PL
United Kingdom
Ouchithorpe Lane
Wakefield
WF1 3SP
United Kingdom
Normanby Road
TS6 0SZ
United Kingdom
Lakeside Mental Health Unit
West Middlesex University Hospital Site
Twickenham Road
Isleworth
TW7 6AF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2020 | 16/09/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Qualitative results of interviews exploring barriers to recruitment | 22/08/2022 | 12/08/2022 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/08/2022: Publication reference added.
16/09/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
30/04/2020: The public contact has been updated and the plain English summary has been updated accordingly.
25/03/2019: The condition was updated from "Specialty: Mental health, Primary sub-specialty: Psychosis - schizophrenia; UKCRC code/ Disease: Mental Health/ Schizophrenia, schizotypal and delusional disorders" to "Antipsychotic-Induced Sexual Dysfunction" following a request from the NIHR.
