跳至主要内容
临床试验/NCT04316650
NCT04316650撤回不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
250
试验地点
1
主要终点
Sexual desire and activity intensity scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • no consent
  • 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

研究组 & 干预措施

Anti-androgen Group

Other

Treated by anti-androgen at inclusion

干预措施: osteodensitometry (Other)

SSRI Group

Other

Treated by ISRS at inclusion

干预措施: Evaluation Scales (Behavioral)

SSRI Group

Other

Treated by ISRS at inclusion

干预措施: osteodensitometry (Other)

SSRI Group

Other

Treated by ISRS at inclusion

干预措施: blood samples (Biological)

SSRI Group

Other

Treated by ISRS at inclusion

干预措施: ECG (Other)

SSRI Group

Other

Treated by ISRS at inclusion

干预措施: Blood and saliva samples (Genetic)

Anti-androgen Group

Other

Treated by anti-androgen at inclusion

干预措施: Evaluation Scales (Behavioral)

Anti-androgen Group

Other

Treated by anti-androgen at inclusion

干预措施: blood samples (Biological)

Anti-androgen Group

Other

Treated by anti-androgen at inclusion

干预措施: ECG (Other)

Anti-androgen Group

Other

Treated by anti-androgen at inclusion

干预措施: Blood and saliva samples (Genetic)

No SSRIs or antiandrogen treatment at inclusion

Other

no treatment

干预措施: Evaluation Scales (Behavioral)

No SSRIs or antiandrogen treatment at inclusion

Other

no treatment

干预措施: osteodensitometry (Other)

No SSRIs or antiandrogen treatment at inclusion

Other

no treatment

干预措施: blood samples (Biological)

No SSRIs or antiandrogen treatment at inclusion

Other

no treatment

干预措施: ECG (Other)

No SSRIs or antiandrogen treatment at inclusion

Other

no treatment

干预措施: Blood and saliva samples (Genetic)

结局指标

主要结局

Sexual desire and activity intensity scale

时间窗: Change from inclusion at 36 months

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)

Incidence of adverse events

时间窗: 36 months

Anti-Androgen Group and no pharmacological treatment group : Report of any adverse event: the type, frequency, time of occurrence of adverse events

次要结局

  • Relapse rate(Every 3 months up to 36 months)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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