For subjects on SSRIs: bone densitometry
RadiationFor subjects on SSRIs:
Bone densitometry is one of the additional examinations considered. This assessment is part of the routine monitoring for subjects on androgens.
Other names: patients on SSRIs
NCT Number: NCT07144943
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.
Trial opening soon.
Get Notified18 year and older
Male
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: patients on SSRIs
Time frame: Baseline
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).
Time frame: 3 months
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.
Time frame: Baseline and 36 months.
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.
Time frame: 3 months
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).
Time frame: At baseline
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.
Time frame: 3 months.
Binary assessment (present/absent) of gynecomastia at baseline and every 3 months.
Time frame: At baseline
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.
Time frame: 3 months
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
Time frame: 3 months
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).
Time frame: 3 months
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.
Time frame: At 36 months
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.
Time frame: Baseline and 36 months.
The PDQ-4+ assesses personality disorder traits. Score range 0-100; higher scores indicate more personality disorder traits (worse outcome).
Time frame: Baseline and 36 months.
The BIS-11 is a self-report questionnaire of impulsivity. Score range 30-120; higher scores indicate greater impulsivity (worse outcome).
Time frame: 3 months.
Mean systolic and diastolic blood pressure values measured at baseline and every 3 months.
Time frame: 3 months.
Mean weight measured at baseline and every 3 months.
Time frame: 3 months.
Description: Molest Scale score, range [min-max to be specified], higher scores indicate greater aggression (worse outcome).
Time frame: 3 months.
Rape Scale score, range [min-max], higher scores indicate higher risk of sexual violence (worse outcome).
Time frame: 3 months.
Range [min-max], higher scores indicate greater empathy (better outcome).
Time frame: 3 months.
Range [min-max], higher scores indicate greater denial (worse outcome).
Time frame: 3 months.
AUDIT total score (0-40). Higher scores indicate more hazardous or harmful drinking (worse outcome).
Time frame: 3 months.
Self-reported consumption of illicit drugs (type, grams/day, duration). Reported at baseline and every 3 months.
Time frame: 3 months.
PATHOS score range 0-5, PEACCE [specify range]. Higher scores indicate higher risk of hypersexuality (worse outcome).
Time frame: 3 months.
CSBI score range [min-max], higher scores indicate greater compulsive sexual behavior (worse outcome).
Time frame: 3 months.
STATIC-99 score range 0-12; higher scores indicate greater risk of sexual violence recidivism (worse outcome).
Time frame: 3 months.
STABLE-2007 score range 0-26; higher scores indicate greater dynamic risk factors for sexual recidivism (worse outcome).
Time frame: Baseline
MoCA score range 0-30; higher scores indicate better cognitive function.
Time frame: Baseline
Stroop performance (reaction time in seconds and number of errors). Longer reaction times and more errors indicate worse cognitive function.
Contact information is provided by the study sponsor or research team.
Florence THIBAUT, Professor
CONTACT
01 58411679 ext. +(33)
Ouiza MANSEUR Ouiza, Project manager
CONTACT
01 45 65 84 86 ext. +(33)
Centre Hospitalier St Anne
Other
Study on the Observation of the Evolution of Sexual Symptoms in Sexual Offenders With Paraphilia (With or Without Antiandrogen or SSRI Treatments)
Acronym: ESPARA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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