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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01543-44 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients on antiandrogens | standard care |
| |
| patients on SSRI | selective serotonin reuptake inhibitors |
| |
| patient without pharmacological treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Presence of psychiatric disorders according to DSM-5 criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence THIBAUT, Professor | Contact | 01 58411679 | +(33) | florence.thibaut@aphp.fr |
| Ouiza MANSEUR Ouiza, Project manager | Contact | 01 45 65 84 86 | +(33) | ouiza.manseur@ghu-paris.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florence THIBAUT, Professor | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2025 | Aug 20, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consentement éclairé pour patient majeur | Feb 7, 2025 | Aug 20, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consentement éclairé pour patient sous curatelle | Feb 7, 2025 | Aug 20, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D010262 | Paraphilic Disorders |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D001523 | Mental Disorders |
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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. |
| Baseline and 36 months. |
| 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). | 3 months |
| 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. | At baseline |
| Presence of clinically observable gynecomastia | Binary assessment (present/absent) of gynecomastia at baseline and every 3 months. | 3 months. |
| Traumatic life events (THQ - Trauma History Questionnaire) | Outcome: Total score on the Trauma History Questionnaire (THQ). Measurement: THQ is a self-report questionnaire assessing the presence and frequency of traumatic events over the lifetime. Scale: The French version used in the study includes a series of items scored from 0 (no occurrence) to a maximum determined by the number of events endorsed (higher scores indicate a greater number of traumatic events). Scoring interpretation: Higher scores reflect a worse outcome, meaning greater exposure to traumatic life events. | At baseline |
| Change in clinical management - Comorbidity | Number of participants whose comorbidity profile changes during the 36-month follow-up. Measurement: Recorded at each 3-month visit, based on DSM-5 diagnosis status (present/absent for each condition | 3 months |
| Change in clinical management - Treatment tolerance | Number of participants with changes in clinical management due to treatment-related adverse events. Measurement: Recorded at each 3-month visit; events classified by type, severity, and relationship to treatment (CTCAE v4.0). | 3 months |
| Change in clinical management - Sexual symptoms evolution | Outcome: Change from baseline in sexual symptom scores leading to a modification of clinical management. Measurement: Difference in scores from validated sexual symptoms scales (libido, fantasies, sexual activity), measured every 3 months over 36 months. | 3 months |
| Change in treatment adherence - Serum testosterone level | Outcome: Change from baseline in serum testosterone concentration at 36 months in participants receiving SSRIs or antiandrogens. Measurement: Measured in ng/dL at baseline and when non-adherence is suspected; lower levels are expected in adherent participants on antiandrogen treatment. | At 36 months |
| Personality traits measured with the Personality Diagnostic Questionnaire-4+ (PDQ-4+) | The PDQ-4+ assesses personality disorder traits. Score range 0-100; higher scores indicate more personality disorder traits (worse outcome). | Baseline and 36 months. |
| Impulsivity measured with the Barratt Impulsiveness Scale, Version 11 (BIS-11) | The BIS-11 is a self-report questionnaire of impulsivity. Score range 30-120; higher scores indicate greater impulsivity (worse outcome). | Baseline and 36 months. |
| Change in systolic and diastolic blood pressure (mmHg) | Mean systolic and diastolic blood pressure values measured at baseline and every 3 months. | 3 months. |
| Change in body weight (kg) | Mean weight measured at baseline and every 3 months. | 3 months. |
| Aggression measured with the Molest Scale | Description: Molest Scale score, range [min-max to be specified], higher scores indicate greater aggression (worse outcome). | 3 months. |
| Sexual violence risk measured with the Rape Scale | Rape Scale score, range [min-max], higher scores indicate higher risk of sexual violence (worse outcome). | 3 months. |
| Empathy score [specify full name of empathy scale] | Range [min-max], higher scores indicate greater empathy (better outcome). | 3 months. |
| Denial score [specify full name of denial scale] | Range [min-max], higher scores indicate greater denial (worse outcome). | 3 months. |
| Alcohol use measured with the Alcohol Use Disorders Identification Test (AUDIT) | AUDIT total score (0-40). Higher scores indicate more hazardous or harmful drinking (worse outcome). | 3 months. |
| Illicit drug use (type, quantity, duration) | Self-reported consumption of illicit drugs (type, grams/day, duration). Reported at baseline and every 3 months. | 3 months. |
| Hypersexuality screening with PATHOS and PEACCE | PATHOS score range 0-5, PEACCE [specify range]. Higher scores indicate higher risk of hypersexuality (worse outcome). | 3 months. |
| Compulsive sexual behavior measured with the Compulsive Sexual Behavior Inventory (CSBI) | CSBI score range [min-max], higher scores indicate greater compulsive sexual behavior (worse outcome). | 3 months. |
| Sexual violence risk measured with the STATIC-99 | STATIC-99 score range 0-12; higher scores indicate greater risk of sexual violence recidivism (worse outcome). | 3 months. |
| Sexual risk factors measured with the STABLE-2007 | STABLE-2007 score range 0-26; higher scores indicate greater dynamic risk factors for sexual recidivism (worse outcome). | 3 months. |
| Cognitive function measured with the Montreal Cognitive Assessment (MoCA) | MoCA score range 0-30; higher scores indicate better cognitive function. | Baseline |
| Cognitive flexibility measured with the Stroop Test | Stroop performance (reaction time in seconds and number of errors). Longer reaction times and more errors indicate worse cognitive function. | Baseline |