FASAR - RCT of fluoxetine for treatment of problematic sexual arousal
Research type
Research Study
Full title
Randomised controlled trial of fluoxetine for the treatment of problematic sexual arousal in adult males serving a custodial sentence
IRAS ID
1007974
Contact name
Adarsh Kaul
Contact email
Sponsor organisation
Nottingham Trent University
Clinicaltrials.gov Identifier
N/A
Research summary
Problematic sexual arousal (PSA) is characterised by persistent and intense sexual thoughts, physiological arousal, urges, and behaviours that are distressing and difficult to control. Prisons have people with symptoms of PSA being exhibited during their stay.
Recent research has provided evidence for selective serotonin reuptake inhibitors (SSRIs) as an alternative treatment to testosterone-lowering medications. A number of research studies have been conducted into the use of various SSRIs (mainly sertraline and fluoxetine). These studies have reported promising results for the role of SSRIs in the treatment of PSA, including a less severe side effect profile and cost-effectiveness.
This trial aims to investigate whether fluoxetine can reduce PSA in patients who have been referred to the prison’s Medication to Manage Problematic Sexual Arousal (MMPSA) service by comparing its effectiveness and cost effectiveness over a 6 month period when compared with patients taking a placebo drug. We will undertake a double blind randomised controlled trial, recruiting at least 196 patients and randomising them to fluoxetine or a matching placebo in a 1:1 ratio so that there are equal numbers in each group. We will ask patients to complete questionnaires at baseline (before the blinded treatment is given), then at 3 and 6 months after the treatment has been started. Patients will complete a daily log to report any side effects, changes to other medications they are taking, and any healthcare contacts during the trial.
At the end of the 6 month trial period for each patient, the Forensic Psychiatrist will be unblinded and decide on their treatment as part of standard care.
The trial hopes to prove that fluoxetine is effective and cost effective to use in patients exhibiting PSA symptoms so that the guidelines can be amended to allow fluoxetine to be prescribed in the community.REC name
Wales REC 3
REC reference
26/WA/0041
Date of REC Opinion
20 Apr 2026
REC opinion
Further Information Favourable Opinion