"Evolution of Sexual Symptoms in Paraphilic Sexual Offenders With/Without Antiandrogen or SSRI Treatment"
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: For subjects on SSRIs: bone densitometry.
- Who it may be relevant to
- Registry conditions: Sexual Disorder, Physiological. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study on the Observation of the Evolution of Sexual Symptoms in Sexual Offenders With Paraphilia (With or Without Antiandrogen or SSRI Treatments)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in sexual desire and paraphilic behavior scores using the Intensity of Sexual Desire and Sexual Symptoms Scale (ISDSS, self-report) [Time frame: Baseline]
Secondary outcome measures (12)
- Sexual relapse occurrence [Time frame: 3 months]
- Presence of psychiatric disorders according to DSM-5 criteria [Time frame: Baseline and 36 months.]
- Change in treatment adherence - Brief Adherence Rating Scale [Time frame: 3 months]
- Treatment-related adverse events [Time frame: At baseline]
- Presence of clinically observable gynecomastia [Time frame: 3 months.]
- Traumatic life events (THQ - Trauma History Questionnaire) [Time frame: At baseline]
- Change in clinical management - Comorbidity [Time frame: 3 months]
- Change in clinical management - Treatment tolerance [Time frame: 3 months]
- Change in clinical management - Sexual symptoms evolution [Time frame: 3 months]
- Change in treatment adherence - Serum testosterone level [Time frame: At 36 months]
- Personality traits measured with the Personality Diagnostic Questionnaire-4+ (PDQ-4+) [Time frame: Baseline and 36 months.]
- Impulsivity measured with the Barratt Impulsiveness Scale, Version 11 (BIS-11) [Time frame: Baseline and 36 months.]
Eligibility criteria
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."
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07144943 · D24-P008 · 2024-A01543-44