Study of Maintenance of the Efficiency and Adverse Effects of Pharmacological Treatments in Sex Offenders With Paraphilia
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
- 否
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
Treated by anti-androgen at inclusion
干预措施: osteodensitometry (Other)
SSRI Group
Treated by ISRS at inclusion
干预措施: Evaluation Scales (Behavioral)
SSRI Group
Treated by ISRS at inclusion
干预措施: osteodensitometry (Other)
SSRI Group
Treated by ISRS at inclusion
干预措施: blood samples (Biological)
SSRI Group
Treated by ISRS at inclusion
干预措施: ECG (Other)
SSRI Group
Treated by ISRS at inclusion
干预措施: Blood and saliva samples (Genetic)
Anti-androgen Group
Treated by anti-androgen at inclusion
干预措施: Evaluation Scales (Behavioral)
Anti-androgen Group
Treated by anti-androgen at inclusion
干预措施: blood samples (Biological)
Anti-androgen Group
Treated by anti-androgen at inclusion
干预措施: ECG (Other)
Anti-androgen Group
Treated by anti-androgen at inclusion
干预措施: Blood and saliva samples (Genetic)
No SSRIs or antiandrogen treatment at inclusion
no treatment
干预措施: Evaluation Scales (Behavioral)
No SSRIs or antiandrogen treatment at inclusion
no treatment
干预措施: osteodensitometry (Other)
No SSRIs or antiandrogen treatment at inclusion
no treatment
干预措施: blood samples (Biological)
No SSRIs or antiandrogen treatment at inclusion
no treatment
干预措施: ECG (Other)
No SSRIs or antiandrogen treatment at inclusion
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)
