"Evolution of Sexual Symptoms in Paraphilic Sexual Offenders With/Without Antiandrogen or SSRI Treatment"
NCT07144943, Not yet recruiting, Centre Hospitalier St Anne
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | "Evolution of Sexual Symptoms in Paraphilic Sexual Offenders With/Without Antiandrogen or SSRI Treatment" | ClinicalTrials.gov |
| NCT number | NCT07144943 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Centre Hospitalier St Anne | ClinicalTrials.gov |
| Conditions | Sexual Disorder, Physiological | ClinicalTrials.gov |
| Interventions | For subjects on SSRIs: bone densitometry | ClinicalTrials.gov |
| First posted | 2025-08-28 | ClinicalTrials.gov |
| Last updated | 2025-08-28 | ClinicalTrials.gov |
Registered outcomes 27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in sexual desire and paraphilic behavior scores using the Intensity of Sexual Desire and Sexual Symptoms Scale (ISDSS, self-report) | 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). | ClinicalTrials.gov |
| Secondary | Sexual relapse occurrence | 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. | ClinicalTrials.gov |
| Secondary | Presence of psychiatric disorders according to DSM-5 criteria | 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. | ClinicalTrials.gov |
| Secondary | Change in treatment adherence - Brief Adherence Rating Scale | 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). | ClinicalTrials.gov |
| Secondary | Treatment-related adverse events | 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. | ClinicalTrials.gov |
| Secondary | Presence of clinically observable gynecomastia | 3 months. | Binary assessment (present/absent) of gynecomastia at baseline and every 3 months. | ClinicalTrials.gov |
| Secondary | Traumatic life events (THQ - Trauma History Questionnaire) | 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. | ClinicalTrials.gov |
| Secondary | Change in clinical management - Comorbidity | 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 | ClinicalTrials.gov |
| Secondary | Change in clinical management - Treatment tolerance | 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). | ClinicalTrials.gov |
| Secondary | Change in clinical management - Sexual symptoms evolution | 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. | ClinicalTrials.gov |
| Secondary | Change in treatment adherence - Serum testosterone level | 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. | ClinicalTrials.gov |
| Secondary | Personality traits measured with the Personality Diagnostic Questionnaire-4+ (PDQ-4+) | Baseline and 36 months. | The PDQ-4+ assesses personality disorder traits. Score range 0-100; higher scores indicate more personality disorder traits (worse outcome). | ClinicalTrials.gov |
| Secondary | Impulsivity measured with the Barratt Impulsiveness Scale, Version 11 (BIS-11) | 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). | ClinicalTrials.gov |
| Secondary | Change in systolic and diastolic blood pressure (mmHg) | 3 months. | Mean systolic and diastolic blood pressure values measured at baseline and every 3 months. | ClinicalTrials.gov |
| Secondary | Change in body weight (kg) | 3 months. | Mean weight measured at baseline and every 3 months. | ClinicalTrials.gov |
| Secondary | Aggression measured with the Molest Scale | 3 months. | Description: Molest Scale score, range \[min-max to be specified\], higher scores indicate greater aggression (worse outcome). | ClinicalTrials.gov |
| Secondary | Sexual violence risk measured with the Rape Scale | 3 months. | Rape Scale score, range \[min-max\], higher scores indicate higher risk of sexual violence (worse outcome). | ClinicalTrials.gov |
| Secondary | Empathy score [specify full name of empathy scale] | 3 months. | Range \[min-max\], higher scores indicate greater empathy (better outcome). | ClinicalTrials.gov |
| Secondary | Denial score [specify full name of denial scale] | 3 months. | Range \[min-max\], higher scores indicate greater denial (worse outcome). | ClinicalTrials.gov |
| Secondary | Alcohol use measured with the Alcohol Use Disorders Identification Test (AUDIT) | 3 months. | AUDIT total score (0-40). Higher scores indicate more hazardous or harmful drinking (worse outcome). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)