Brief Summary

This research concerns the evaluation of the maintenance of the efficiency and incidence of adverse effects of pharmacological treatments in sex offenders with paraphilia. Despite the increasing use of pharmacological treatments in these indications, there are few data to indicate which sex offender populations benefit from which pharmacological treatments and which adverse events are observed, particularly with anti-androgens or antidepressant treatments that are widely used in these subjects. A recent Cochrane study showed that psychodynamic treatment is less effective in terms of sexual delinquency compared to probation alone and has not shown significant efficacy of cognitive behavioral therapy (CBT) compared to the lack of treatment, except for a study in which anti-androgen therapy was associated with CBT. Another recent study concluded that the tolerance, even of anti-androgenic drugs, was uncertain, as all studies were small and of limited duration, and new research is needed in the future. Further research demonstrating the efficacy of SSRIs in the treatment of paraphilic disorders is still needed and long-term studies are lacking. Their use for this indication is still off label. As far as we know, this cohort should be the largest population of paraphilic sex offenders studied for the longest time to date in a field where research is insufficient. This large sample receiving routine care and followed for 3 years should allow to analyse the maintenance of the effectiveness of the pharmacological treatments received (SSRIs or anti-androgens), and their tolerance. In addition, this analysis of clinical practices should be crucial to improve the knowledge of the indications for these treatments, which could possibly be reviewed with respect to their effectiveness and tolerance, especially in the most serious cases of paraphilic sex offenders.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline

17mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.3 years study duration

Study Progress68%

Jun 2023Oct 2027

First Submitted

Initial submission to the registry

September 2, 2019

Completed

7 months until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed

3.2 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

September 2, 2019

Last Update Submit

February 11, 2026

Conditions

Paraphilia

Keywords

ParaphiliaSSRI anti-androgenPsychological treatmentPreservation of efficiencyPharmacological treatmentSide effects

Outcome Measures

Primary Outcomes (2)

Sexual desire and activity intensity scale
ISRS Group and no pharmacological treatment group : Treatment efficiency : Sexual desire intensity and scale to measure deviant and non deviant sexual behavior symptoms. (Lickert's scale, scale range : 0 to 7)
Change from inclusion at 36 months
Incidence of adverse events
Anti-Androgen Group and no pharmacological treatment group : Report of any adverse event: the type, frequency, time of occurrence of adverse events
36 months

Secondary Outcomes (6)

Sexual desire intensity scale
Every 3 months up to 36 months
Incidence of adverse events
Every 3 months up to 36 months
Clinical factors
Every 3 months up to 36 months
Psychological factors
Every 3 months up to 36 months
Demographic factors
Every 3 months up to 36 months
+1 more secondary outcomes

Study Arms (3)

SSRI Group

OTHER

Treated by ISRS at inclusion

Behavioral: Evaluation ScalesOther: osteodensitometryBiological: blood samplesOther: ECGGenetic: Blood and saliva samples

Anti-androgen Group

OTHER

Treated by anti-androgen at inclusion

Behavioral: Evaluation ScalesOther: osteodensitometryBiological: blood samplesOther: ECGGenetic: Blood and saliva samples

No SSRIs or antiandrogen treatment at inclusion

OTHER

no treatment

Behavioral: Evaluation ScalesOther: osteodensitometryBiological: blood samplesOther: ECGGenetic: Blood and saliva samples