Problematic sexual arousal Mental and Behavioural Disorders
Conditions
Interventions
The main study is designed as a double-blind randomised controlled superiority trial with two arms. Eligible consenting patients will be randomised to receive either fluoxetine (20mg capsule) or place
Sponsors
Nottingham Trent University
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male. 2. Aged 18+ years. 3. Currently detained at one of the prison sites running the trial and referred to the MMPSA service 4. Total Sexual Compulsivity Scale score (used in standard care) of 15+ or a score of 3 or 4 on any one item. 5. Diagnosis of problematic sexual arousal made by a Forensic Psychiatrist or other relevant specialist. 6. Clinician determination that it is appropriate to prescribe fluoxetine. 7. Understands written and verbal English sufficiently to have the trial explained to them. 8. Has the capacity to give informed consent. 9. Agrees to use appropriate contraceptive methods during the trial and for 6 months after.
Exclusion criteria
Exclusion criteria: 1. Current pharmacological treatment with an SSRI/anti-androgen/Gonadotropin-releasing hormone agonist. 2. Contraindication to Selective serotonin reuptake inhibitors. 3. Major mental illness (e.g. schizophrenia or other psychotic disorders) if acutely unwell and therefore unable to give informed consent. 4. Patients with epilepsy. 5. Currently prescribed medication that interacts with the 5-HT system, meaning it has serotonin effects. 6. Currently on prophylactic medication that has an impact on sexual arousal. 7. Currently prescribed testosterone/oestrogen supplement therapy. 8. Risk of harm to self/others is deemed too high to be randomised to placebo. 9. Planned release date is within 9 months (including shortened sentences). 10. Prison transfer to a prison where Medication to Manage Problematic Sexual Arousal service is not available within the next 9 months is highly likely or actually planned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of fluoxetine in reducing problematic sexual arousal in adult males referred to the Medication to Manage Problematic Sexual Arousal service compared to placebo as measured by the trial-adapted Sexual Compulsivity Scale at baseline and 6 months later. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the efficacy of fluoxetine for improving wellbeing in adult males referred to the MMPSA service compared to placebo using the Warwick–Edinburgh Mental Wellbeing Scale (WEMWBS) at 3 and 6 months. The WEMWBS consists of 14 positively phrased Likert items. The scoring range for each item is from 1–5 and the total score is from 14–70, with higher scores indicating greater wellbeing. 2. To determine the efficacy of fluoxetine for improving anxiety and depression in adult males referred to the MMPSA service compared to placebo using the Hospital Anxiety and Depression Scale (HADS) at 3 and 6 months. This scale provides separate scores for anxiety and depression, with the minimum possible score for each sub-scale being 0, and the maximum being 21. Scores between 0–7 are interpreted as normal, 8–10 as mild, 11–15 as moderate, and 16 or over as severe. 3. To determine the efficacy of fluoxetine for reducing paedophilic and/or hebophilic interests in adult males referred to the MMPSA service compared to placebo using the Problematic Sexual Interest Questionnaire (PSIQ) at 3 and 6 months. 4. The Treatment Considerations and the Experience and Impact sections of the PROMs booklet will be used to understand referral behaviours by patients and their experiences of the MMPSA pathway at 3 and 6 months. Further validation and concurrent validation of the PSIQ will be undertaken during the trial. 5. To assess the cost-effectiveness of fluoxetine compared to placebo using QALYs derived from the EQ5D-5L and the trial-adapted Sexual Compulsivity Scale at 3 and 6 months. QALYs will be calculated using utility data collected from the EQ5D-5L, which is a preference-based measure consisting of five questions with five levels of response; these are converted into utility-index scores ranging from 0 to 1, where a higher score indicates a better quality of life. | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactRichard Emes
Outcome results
None listed