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

Centre Hospitalier St Anne

Status

Not yet enrolling

Conditions

Sexual Disorder, Physiological

Treatments

Radiation: For subjects on SSRIs: bone densitometry

Study type

Observational

Funder types

Other

Identifiers

NCT07144943

2024-A01543-44 (Other Identifier)

D24-P008

Details and patient eligibility

About

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.

Full description

This is a prospective longitudinal cohort study including 200 male participants aged 18-65 years, diagnosed with a paraphilic disorder according to DSM-5, and convicted of sexual offenses (e.g., exhibitionism, rape, sexual assault, incest, possession of child sexual abuse material). Participants are recruited in their usual care setting, after providing informed consent, and assigned to one of three cohorts based on current treatment: antiandrogens, SSRIs, or no pharmacological treatment.

Over a 3-year follow-up period, participants undergo standardized assessments every 3 months, including:

Measurement of sexual desire intensity and deviant sexual symptoms (validated self-report scales).

Recording of any relapses (self-reported, third-party notifications). Evaluation of psychiatric comorbidities (DSM-5), personality disorders (PDQ-4+), impulsivity (BIS-11), and treatment adherence (BARS).

Biological analyses (testosterone levels and others) and regular clinical examinations.

Cognitive and psychological assessments (empathy, denial, cognitive distortions, hypersexuality, alcohol/drug use).

Documentation of traumatic life events (THQ). Optional genetic study through saliva and blood sampling. The study does not initiate or modify treatment; all medical decisions remain under the responsibility of the treating physician. Any adverse effects are systematically documented. Data will be analyzed within each group and, when appropriate, compared between groups after statistical adjustment.

The project is funded by a national PHRC grant and has received ethics committee approval. Additional risks for participants are considered minimal, as all assessments and examinations align with standard care practices.

Enrollment

200 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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."

Exclusion criteria

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."