NCT07144943

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

Study on the Observation of the Evolution of Sexual Symptoms in Sexual Offenders With Paraphilia (With or Without Antiandrogen or SSRI Treatments)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Centre Hospitalier St Anne · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sexual Disorder, Physiological

Interventions

Type	Name	Description
RADIATION	For subjects on SSRIs: bone densitometry	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.

Timeline

• Start date: 2025-09-15
• Primary completion: 2030-09-01
• Completion: 2030-09-01
• First posted: 2025-08-28
• Last updated: 2025-08-28