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

NCT07144943 | Not Yet Recruiting

• 2 other identifiers: D24-P0082024-A01543-44
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sexual Disorder, Physiological

Keywords

sexual offenders; paraphilia; ESPARA

Outcome Measures

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).

  Baseline

Secondary Outcomes (26)

• Sexual relapse occurrence

  3 months

• Presence of psychiatric disorders according to DSM-5 criteria

  Baseline and 36 months.

• Change in treatment adherence - Brief Adherence Rating Scale

  3 months

• Treatment-related adverse events

  At baseline

• Presence of clinically observable gynecomastia

  3 months.

Study Arms (3)

patients on antiandrogens

standard care

Radiation: For subjects on SSRIs: bone densitometry

patients on SSRI

selective serotonin reuptake inhibitors

Radiation: For subjects on SSRIs: bone densitometry

patient without pharmacological treatment

Interventions

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.

Also known as: patients on SSRIs

patients on SSRI; patients on antiandrogens

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• 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,
• Patients covered by social security,
• Satisfactory command of written and spoken French."

You may not qualify if:

• 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."

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Paraphilic Disorders

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Mental Disorders

Study Officials

• Florence THIBAUT, Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence THIBAUT, Professor

CONTACT

01 58411679; florence.thibaut@aphp.fr

Ouiza MANSEUR Ouiza, Project manager

CONTACT

01 45 65 84 86; ouiza.manseur@ghu-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 28, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 28, 2025

Record last verified: 2025-08