Condition category
Mental and Behavioural Disorders
Date applied
24/04/2006
Date assigned
07/06/2006
Last edited
05/02/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Don Grubin

ORCID ID

Contact details

University of Newcastle
North Tyneside and Northumberland Mental Health Trust
St Nicholas Hospital
Jubilee Road
Gosforth
Newcastle-upon-Tyne
NE3 4ES
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MRD 12/92

Study information

Scientific title

Acronym

HSF-SSRI

Study hypothesis

To determine whether either the healthy sexual functioning (HSF) module of the sex offenders treatment programme or selective serotonin reuptake inhibitor (SSRI) medication have a positive impact on relevant psychological mechanisms associated with sexual offending

Ethics approval

Approved by South East MultiCentre Research Ethics Committee, Kent on 18/10/2005, reference number: 05/MRE01/82

Study design

HSF: Randomised, open controlled parallel study. SSRI: Randomised, double-blind, placebo-controlled parallel study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Deviant sexual arousal

Intervention

HSF evaluation: consenting eligible subjects will be randomised to either treatment with the HSF module (receiving treatment in the next available treatment slot) or a waiting list control group (receiving HSF treatment after study assessments have been completed).

SSRI evaluation: consenting eligible subjects will be randomised to either fluoxetine or placebo for a period of 20-26 weeks (the randomisation will be balanced for allocated group in the HSF evaluation, if consent is given for this evaluation also).

Added 05/02/10: trial stopped by 2007 because of recruitment problems.

Intervention type

Drug

Phase

Not Specified

Drug names

Fluoxetine

Primary outcome measures

The multiphasic sex inventory - sexual obsessions sub-scale

Secondary outcome measures

HSF: penile plethysmography and impulsivity scale (sex offender treatment programme)

SSRI only:
1. Fantasy visual analogue scale
2. Sexual outlet inventory
3. Yale-brown obsessive-compulsive scale
4. Hospital anxiety and depression scale
5. Mood visual analogue scale and Udvalg for Kliniske Undersogelser (UKU) side effect rating

Overall trial start date

01/09/2006

Overall trial end date

01/09/2009

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

Consent to treatment in HSF module of HM prison sex offender treatment programme with written informed consent.

In addition, for SSRI sub-study, any one of the following:
1. Sexual preoccupation (either from clinical assessment or based on the multiphasic sex inventory [MSI] obsession scale)
2. A compulsive aspect to their offending (based on clinical judgement)
3. Mood state being an important contributor to their offending (based on clinical judgement)
4. Impulsivity (based on clinical judgement or impulsivity score)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

240 in each evaluation (maximum 480 participants)

Participant exclusion criteria

HSF evaluation: urgent treatment need as assessed by the treatment manager

SSRI sub-study only:
1. Presence of psychotic disorder or major mood disorder, epilepsy, uncontrolled seizure disorders, diabetes, major cardiac problems or severe renal failure.
2. Concomitant treatment with psychoactive medication which may interact with the effects of the SSRI e.g. neuroleptic or antidepressant medication
3. Concomitant treatment with an anti-androgen
4. Concomitant treatment with an anti-coagulant
5. Current treatment, or treatment within the last 4 weeks with SSRI
6. Previous adverse reaction to an SSRI

Recruitment start date

01/09/2006

Recruitment end date

01/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Newcastle
Newcastle-upon-Tyne
NE3 4ES
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

c/o Ms Kay Pattison
Section Head National Health Service (NHS) Research and Development Programmes
University of Liverpool
Health and Community Care Research Unit (HaCCRU)
Thompson-Yates Building
Brownlow Hill
Liverpool
L69 3GB
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Forensic Mental Health Research and Development Programme, reference number: MRD 12/92, http://www.nfmhp.org.uk/ (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes