E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Deviant Sexual Arousal (sex offender) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063494 |
E.1.2 | Term | Sexual offence |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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NOTE - TSC will take on dual role of TSC and DMEC (as agreed by funder)
The end of the study will be the date of last subject's last study medication or final assessment (whichever is later).
The trial may be prematurely discontinued on the basis of insufficient recruitment to power the trial, new safety information, or for other reasons given by the regulatory authority or ethics committee concerned. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |