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ParaphiliaESPARANCT04316650

Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia

A study testing Evaluation Scales, osteodensitometry and blood samples in people with Paraphilia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, men only
Conditions the study is for
Paraphilia
What is being tested?
Evaluation Scales, osteodensitometry and blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteFrance
Study dates
Jun 2023to Oct 2027
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Man
  • At least one sex offence
  • Paraphilia (DSM-5 criteria )
  • Receiving pharmacological treatment ( ISRS or anti-androgen or none of them)
  • Age between 18 and 65 years
  • Patient 100% covered by social security

Who cannot join

  • no consent
  • female
  • aged under 18 or over 65 years
  • subject receiving simultaneous ISRS and anti-androgen treatment before enrolment
  • incarcerated
  • Subject under guardianship (patients under curatorship may however be included),
  • no social security registration
  • contraindications or allergies to treatments

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Cochin

    Paris, 75014

Other trials in France

About this study

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.

Read the detailed description

This research uses a "naturalistic" follow-up method (over 3 years). The main objectives focuses on two main issues that are important in clinical practice: (1) the tolerance of anti-androgenic treatments traditionally used for many years in young sexual offenders with severe paraphilias (2) the maintenance of the efficiency of SSRIs not yet approved for this indication (despite their current use in the treatment of minor paraphilic disorders).

The paraphilic sex offender population are divided into three groups: those receiving SSRIs, those receiving anti-androgens (either GnRH agonists or CPA) and those receiving no pharmacological treatment.

Conditions
Paraphilia
Being tested
Evaluation Scales, osteodensitometry, blood samples, ECG, Blood and saliva samples
Keywords
Paraphilia, SSRI anti-androgen, Psychological treatment, Preservation of efficiency, Pharmacological treatment, Side effects
Medical subject headings
Paraphilic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation ScalesBehavioural

    • PATHOS / PEACCE : hypersexuality diagnostic scale
    • PDQ-4+: Personality Diagnostic Questionnaire version 4
    • AUDIT
    • Life trajectory : THQ
    • Cognitive function (MoCA, Stroop)
    • ISDSS: and self report of sexual activity and desire
    • BARS: Brief Adhesion Rating Scale (treatment observance)
    • SF-36 scale : quality of life
    • BDI-II : Beck Depression Inventory
    • BSSI ; Beck suicidal Inventory
    • Cognitive functioning evaluation : Molest and Rape Scale
    • Empathy: EMPAT
    • Evaluation of Cognitive functioning: denial evaluation and Mc Kibben minimization
    • Baratt Impulsivity Scale
    • CSBI
    • Static 99 and Stable 2007

  • osteodensitometryOther

    Osteodensitometry

  • blood samplesBiological

    • Lipid profile (total cholesterol, triglycerides, HDL cholesterol)
    • Liver function (ASAT, ALAT, total bilirubin, transferase gamma-glutamyl et alcalin phosphatases
    • Kydney function
    • Blood count
    • Biological Measurements and Measurement of Systematic Plasma Testosterone and TeBG Levels in Sex Offenders check for pathology of the Gonadotropin Axis
    • Biological Measurements of Plasma Prolactin level

  • ECGOther

    ECG (heart rate, search for cardiac conduction disorders or cardiac arrhythmias)

  • Blood and saliva samplesGenetic

    Blood and saliva samples

Study groups in NCT04316650
Study groupRoleWhat they receive
SSRI GroupOtherTreated by ISRS at inclusion
Receives: Behavioral: Evaluation Scales; Other: osteodensitometry; Biological: blood samples; Other: ECG; Genetic: Blood and saliva samples
Anti-androgen GroupOtherTreated by anti-androgen at inclusion
Receives: Behavioral: Evaluation Scales; Other: osteodensitometry; Biological: blood samples; Other: ECG; Genetic: Blood and saliva samples
No SSRIs or antiandrogen treatment at inclusionOtherno treatment
Receives: Behavioral: Evaluation Scales; Other: osteodensitometry; Biological: blood samples; Other: ECG; Genetic: Blood and saliva samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Change from inclusion at 36 months

  2. 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

    Measured: 36 months

Secondary outcomes (6)

  1. Sexual desire intensity scale

    Anti-Androgen Group : Treatment efficiency : Sexual desire intensity and scale to measure deviant and non deviant sexual behavior symptoms

    Measured: Every 3 months up to 36 months

  2. Incidence of adverse events

    ISRS Group: Report of any adverse event: the type, frequency, time of occurrence of adverse events

    Measured: Every 3 months up to 36 months

  3. Clinical factors

    All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account clinical factors listed above.

    Measured: Every 3 months up to 36 months

  4. Psychological factors

    All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account psychological factors listed above.

    Measured: Every 3 months up to 36 months

  5. Demographic factors

    All groups : Maintenance of efficacy and incidence of side effects will be analysed taking into account demographic factors listed above.

    Measured: Every 3 months up to 36 months

  6. Relapse rate

    Must stay rare event (low expected number, sexual offense risk evaluated in literature around 10%when the treatment is controlled regularly, the relapses are statistically analysed if the numbers is sufficient, but it can not be a principal assessment because of their rarity).

    Measured: Every 3 months up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2020
  2. Study startJun 2023 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionOct 2027 (estimated)

Why it stopped: Change of sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04316650
Sponsor's protocol ID
P150962J
Other IDs
2017-004984-11, 2017
Acronym
ESPARA
Status last verified
Feb 2026
First submitted
2 Sep 2019
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Evaluation Scales, osteodensitometry and blood samples in people with Paraphilia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sexual desire and activity intensity scale (time frame: Change from inclusion at 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04316650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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