2024-514490-22-00撤回3 期
Pharmacological treatment of compulsive sexual behaviour disorder
Centrum Medyczne Ksztalcenia Podyplomowego1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2024年9月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- The severity of the perceived “desire” for compulsive sexual behavior
研究概览
简要总结
Comparison of the effects of treatment with escitalopram, paroxetine, naltrexone, and combined treatment (escitalopram plus naltrexone) or placebo on reducing the severity of symptoms of CSBD.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male gender and age 18-60 years
- •Signed informed consent form for participation in the study and consent to the processing of personal data
- •Declared willingness to participate in the procedures included in the study protocol
- •Subjective sense of loss of control over one's sexual behavior (e.g., viewing pornography, masturbation, or use of paid sexual services, etc.),
- •Seeking specialized help/therapy including pharmacotherapy for perceived symptoms or consequences of the symptoms,
- •Documented diagnosis of CSBD according to ICD-11 diagnostic guidelines (WHO, 2022)
排除标准
- •Co-occurrence of mania or bipolar affective disorder, moderate or severe depression episode, psychotic disorders, obsessive-compulsive disorder or cognitive impairment (dementia, mental retardation) according ro ICD-11 diagnostic guidelines (WHO, 2022)
- •Any laboratory result deviating from normal values (laboratory norm) will be analyzed on an individualized basis in conjunction with the participant's clinical condition and medical history. Laboratory deviations that are the basis for the decision not to start or withhold pharmacotherapy, and thus discontinue the patient's participation in the study. 1)aspartate aminotrasferase (AST), alanine aminotransferase (ALT) - activity exceeding 3 times the upper limit of normal 2)hemoglobin < 10 g/dL, 3)leukocytes <3000/µL, 4)platelets <100,000/µL, 3)fasting glucose > 120 mg%. 4)creatinine - increase in concentration exceeding 1.5 times the upper limit of normal 5)eGFR ≤ 50 ml/min/1.73m2 6)sodium - hyponatremia < 126 mmol/L or hypernatremia > 150 mmol/L, 7)potassium - hypokalemia ≤ 3 mmol/L, hyperkalemia ≥ 5.9 mmol/L.
- •Current use of antidepressant, anti-anxiety, antipsychotic or mood-stabilizing medications
- •Current use of psychotherapy or other psychological support
- •Clinically significant neurological disorders reported in the medical history
- •Current psychoactive substance dependence, compulsive gambling
- •Positive drug test result
- •Any medical contraindication to the use of escitalopram, paroxetine or naltrexone hydrochloride (according to summary of product characteristics)
- •Use of other drugs that have clinically significant or pharmacokinetic interactions with the investigational medicinal products
- •Other conditions that, in the opinion of the investigator, constitute significant contraindications to participation in the clinical trial, e.g. inability to participate in all study procedures including cognitive impairment to the extent that it is impossible to understand the study procedures and participate in the procedures
结局指标
主要结局
The severity of the perceived “desire” for compulsive sexual behavior
The severity of the perceived “desire” for compulsive sexual behavior
Scores obtained on the CSBD-19 scale
Scores obtained on the CSBD-19 scale
Scores obtained on the BPS scale
Scores obtained on the BPS scale
Frequency of compulsive sexual behavior measured by patient diary data.
Frequency of compulsive sexual behavior measured by patient diary data.
次要结局
- Scores obtained on the HADS scale.
- Scores obtained on the DERS-SF scale.
- Scores obtained on the CSBD-DI scale.
- Scores obtained on the IIEF-15 scale.
- Reactivity to cues of erotic stimuli measured by neuronal indices (amplitude of evoked potentials in EEG) in the Incentive Delay Task
- Scores obtained on the CSBD-19 scale
- The severity of the perceived “desire” for compulsive sexual behavior.
- Scores obtained on the BIS scale.
- Responsiveness to erotic stimulus cues measured by behavioral performance (reaction time and correctness of performance) in the Incentive Delay Task
- Scores obtained on the BPS scale
- Frequency of compulsive sexual behavior measured by patient diary data.
研究者
Ryszard Gellert
Scientific
Centrum Medyczne Ksztalcenia Podyplomowego
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Pharmacological treatment of compulsive sexual behaviour disorder2024-514490-22-01Centrum Medyczne Ksztalcenia Podyplomowego410
进行中（未招募）
1 期
A pilot study to evaluate the possible use and effectiveness of an opiate antagonist for treatment of hypersexual disorder (sex abuse)Hypersexual disorderMedDRA version: 20.0Level: PTClassification code 10066364Term: HypersexualitySystem Organ Class: 10037175 - Psychiatric disordersEUCTR2018-001049-15-SEANOVA (Andrologi, Sexualmedicin, Transmedicin) Karolinska Universitetssjukhuset och Umeå Universitet20
招募中
不适用
Assessing Real Life Effectiveness of Treatment in Neurodevelopmental DisordersConduct DisorderNCT07273695IRCCS Eugenio Medea80
招募中
3 期
BACLOFEN FOR IMPROVING BENZODIAZEPINE TITRATION IN BENZODIAZEPINE DEPENDENCE. BABET2022-502307-30-00Hospices Civils De Lyon93
已完成
2 期
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance TherapyBinge-Eating DisorderObesityNCT03047005Yale University68