"Evolution of Sexual Symptoms in Paraphilic Sexual Offenders With/Without Antiandrogen or SSRI Treatment"

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorCentre Hospitalier St Anne

About this trial

The ESPARA study is a multicenter observational research project aiming to monitor, over a three-year period, the evolution of sexual symptoms in male sexual offenders with paraphilia, divided into three groups: receiving antiandrogen treatment, receiving selective serotonin reuptake inhibitors (SSRIs), or no pharmacological treatment. The primary objective is to assess changes in sexual desire intensity and deviant sexual behaviors, while secondary objectives include relapse rates, the role of psychiatric comorbidities, treatment tolerability, and various clinical, cognitive, and life-history factors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men suffering from paraphilias (DSM-5 criteria),

Aged 18 to 65 years,

Sexual offenders (offense or sexual assault including exhibitionism, rape, sexual touching, incest, possession of pedopornographic video material) (severity level 1 to 6 according to WFSBP recommendations),

Subject who has given consent,

Disqualifiers

Subject in prison (regardless of the reason),

Subject under guardianship (patients under legal supervision may, however, be included),

Subjects who have committed a sexual offense and do not meet the DSM-5 criteria for paraphilia."

Trial population

* Men suffering from paraphilic disorders (DSM-5 criteria), * Aged between 18 and 65 years, * Sexual offenders (offense or sexual assault including exhibitionism, rape, sexual touching, incest, possession of child pornographic video material) (severity level 1 to 6 according to WFSBP guidelines)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • For subjects on SSRIs: bone densitometry

    Radiation

    For subjects on SSRIs: Bone densitometry is one of the additional examinations considered. This assessment is part of the routine monitoring for subjects on androgens.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: patients on antiandrogens1 intervention
Group B: patients on SSRI1 intervention
Group C: patient without pharmacological treatment0 interventions

Trial outcomes

Primary outcomes

1

Change in sexual desire and paraphilic behavior scores using the Intensity of Sexual Desire and Sexual Symptoms Scale (ISDSS, self-report)

The ISDSS assesses three domains of sexual functioning during the past month: Sexual interest and desire (score 0-8; higher = stronger desire) Sexual thoughts and fantasies (score 0-8; higher = more frequent/intense fantasies) Frequency of paraphilic sexual activities per week (e.g., masturbation, sexual activity leading to orgasm; reported as count). The mean score of the three domains (range 0-8) will be calculated. Higher scores indicate worse outcome (greater intensity/frequency of paraphilic sexual behavior).

Time frame
Baseline

Secondary outcomes

1

Sexual relapse occurrence

Number of participants with sexual relapse (recurrence of deviant sexual behavior) during the 36-month follow-up, recorded at each 3-month visit via participant report, third-party notifications, or official records.

Time frame
3 months
2

Presence of psychiatric disorders according to DSM-5 criteria

Categorical diagnosis (present/absent) of psychiatric comorbidities assessed at baseline and 36 months using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

Time frame
Baseline and 36 months.
3

Change in treatment adherence - Brief Adherence Rating Scale

Outcome: Change from baseline in treatment adherence score at 36 months. Measurement: Measured every 3 months using the Brief Adherence Rating Scale (BARS, range 0-6; higher scores indicate better adherence).

Time frame
3 months
4

Treatment-related adverse events

Number of participants with treatment-related adverse events during the 36-month follow-up, documented by type, frequency, onset time, and severity, as reported by the treating physician or participant.

Time frame
At baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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