Deviant Sexual Arousal (sex offender) MedDRA version: 8.1 Level: LLT Classification code 10063494 Term: Sexual offence
Conditions
Interventions
Trade Name: Fluoxetine Capsules (IVAX brand)
Product Name: Fluoxetine
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Department of Health
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: HSF evaluation: • Consent to treatment in HSF module of HM Prison sex offender treatment programme • Written informed consent for HSF evaluation SSRI evaluation: • Consent to treatment in HSF module of HM Prison sex offender treatment programme • Written informed consent for SSRI evaluation And any one of the following: • sexual preoccupation (clinical assessment from SARN or based on the MSI Obsession scale); • a compulsive aspect to their offending (clinical assessment from SARN); • mood state being an important contributor to their offending (clinical assessment from SARN); • impulsivity (clinical assessment from SARN or impulsivity score) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: HSF evaluation: • Urgent treatment need as assessed by the treatment manager SSRI evaluation: • Presence of psychotic disorder or major mood disorder; epilepsy; uncontrolled seizure disorders; diabetes; major cardiac problems; severe renal failure • Concomitant treatment with psychoactive medication which may interact with the effects of the SSRI e.g. neuroleptic or antidepressant medication • Concomitant treatment with an anti-androgen • Concomitant treatment with an anti-coagulant • Current treatment, or treatment within the last 4 weeks with a SSRI • Previous adverse reaction to a SSRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether either the HSF module of the Sex Offenders Treatment Programme or SRRI medication have a positive impact on relevant psychological mechanisms associated with sexual offending.;Secondary Objective: To determine whether either the HSF module of the Sex Offenders Treatment Programme or SSRI medication have a positive impact on: Relevant physiological mechanisms associated with sexual offending; Obsessive compulsive phenomena, mood and impulsivity; Sexual re-offending (not demonstrated within proposed study period but within the HM PRison Service Offending Behaviour programmes Unit research plan).;Primary end point(s): The primary outcome variable is the impact of HSF or SSRI treatment on relevant psychological mechanisms associated with sexual offending, measured using the Multiphasic Sex Inventory Sex Obsession Subscale. | — |
Countries
United Kingdom
Outcome results
None listed