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Clinical Trials/EUCTR2005-003435-40-GB
EUCTR2005-003435-40-GB
Active, not recruiting
Phase 1

A Randomised Controlled Trial to Investigate the effectiveness of the Healthy Sexual Functioning (HSF) Module and Selective Serotonin Reuptake Inhibitor (SSRI) Medication to treat Deviant Sexual Arousal as part of the HM Prison Sex Offender Treatment Programme. - HSF-SSRI Trial

Department of Health0 sites240 target enrollmentSeptember 18, 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Deviant Sexual Arousal (sex offender)
Sponsor
Department of Health
Enrollment
240
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 18, 2006
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility 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);

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

Outcomes

Primary Outcomes

Not specified

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