"Evolution of Sexual Symptoms in Paraphilic Sexual Offenders With/Without Antiandrogen or SSRI Treatment"
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: For subjects on SSRIs: bone densitometry.
- Кому может быть актуально
- Состояния в реестре: Sexual Disorder, Physiological. Базовые параметры: от 18 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Study on the Observation of the Evolution of Sexual Symptoms in Sexual Offenders With Paraphilia (With or Without Antiandrogen or SSRI Treatments)
Обзор
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.
Подробное описание
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.
Вмешательства
- Лучевая терапия 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.
Первичные конечные точки
- Change in sexual desire and paraphilic behavior scores using the Intensity of Sexual Desire and Sexual Symptoms Scale (ISDSS, self-report) [Срок оценки: Baseline]
Вторичные конечные точки (12)
- Sexual relapse occurrence [Срок оценки: 3 months]
- Presence of psychiatric disorders according to DSM-5 criteria [Срок оценки: Baseline and 36 months.]
- Change in treatment adherence - Brief Adherence Rating Scale [Срок оценки: 3 months]
- Treatment-related adverse events [Срок оценки: At baseline]
- Presence of clinically observable gynecomastia [Срок оценки: 3 months.]
- Traumatic life events (THQ - Trauma History Questionnaire) [Срок оценки: At baseline]
- Change in clinical management - Comorbidity [Срок оценки: 3 months]
- Change in clinical management - Treatment tolerance [Срок оценки: 3 months]
- Change in clinical management - Sexual symptoms evolution [Срок оценки: 3 months]
- Change in treatment adherence - Serum testosterone level [Срок оценки: At 36 months]
- Personality traits measured with the Personality Diagnostic Questionnaire-4+ (PDQ-4+) [Срок оценки: Baseline and 36 months.]
- Impulsivity measured with the Barratt Impulsiveness Scale, Version 11 (BIS-11) [Срок оценки: Baseline and 36 months.]
Критерии участия
Критерии включения
- 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."
Критерии исключения
- 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."
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07144943 · D24-P008 · 2024-A01543-44