Department of Clinical Sciences/Psychiatry, Umea University, Umea, Sweden
ANOVA clinic, Karolinska University Hospital, Stockholm, Sweden.
BMJ Open. 2022 Jun 3;12(6):e051756. doi: 10.1136/bmjopen-2021-051756.
Compulsive sexual behaviour disorder is a new disorder in the International Classification of Diseases (ICD-11), and is associated with negative consequences in different areas of life. Evidence for pharmacological treatment of compulsive sexual behaviour disorder is weak and treatment options are limited. This proposed study will be the largest and the first randomised controlled trial comparing the efficacy and tolerability of two active drugs in compulsive sexual behaviour disorder.
Eighty adult participants with compulsive sexual behaviour disorder according to ICD-11 will be randomised to receive either naltrexone 25-50 mg or fluoxetine 20-40 mg for 8 weeks, followed by 6 weeks without treatment. The study will be conducted in a subspecialised outpatient sexual medicine unit at Karolinska University Hospital, Stockholm, Sweden. The study is financed by grants and entirely independent of the manufacturers.Exclusion criteria include severe psychiatric or psychical illness, changes to concurrent medication and non-compatible factors contraindicating the use of either drug. The primary outcome measure is the Hypersexual Disorder: Current Assessment Scale (HD: CAS), and tolerability will be assessed by the Udvalg for Kliniske Undersogelser side effect rating scale (UKU), drug accountability, adherence to treatment and drop-out rate. Participants will complete questionnaires at regular intervals, with the main endpoint for efficacy after 8 weeks (end of treatment) and after 14 weeks (follow-up). Blood chemistry will be repeatedly collected as a safety precaution and for research purposes. The results will be analysed using an appropriate analysis of variance model or a mixed model, depending on the distribution of HD: CAS and the extent of missing data.
The Swedish Ethical Review Authority and the Swedish Medical Products Agency have approved the study on 27 May 2020 and 4 June 2020, respectively (ref. no. 2020-02069 and ref. no. 5.1-2020-48282). Findings will be published in peer-reviewed journals and presented at relevant conferences.
2019-004255-36.
强迫性性行为障碍是《国际疾病分类》（ICD-11）中的一种新障碍，与生活的不同领域的负面后果有关。强迫性性行为障碍的药物治疗证据薄弱，治疗选择有限。这项拟议的研究将是比较两种活性药物在强迫性性行为障碍中的疗效和耐受性的最大和第一项随机对照试验。
80 名根据 ICD-11 诊断为强迫性性行为障碍的成年参与者将被随机分配接受纳曲酮 25-50mg 或氟西汀 20-40mg 治疗 8 周，然后不治疗 6 周。该研究将在瑞典斯德哥尔摩卡罗林斯卡大学医院的一个专门的门诊性医学单位进行。该研究由拨款资助，与制造商完全独立。排除标准包括严重的精神或心理疾病、同时服用的药物改变以及使用任何药物的不相容因素。主要结局指标是性强迫障碍：当前评估量表（HD：CAS），耐受性将通过临床研究评估量表（UKU）、药物可追溯性、治疗依从性和脱落率来评估。参与者将定期完成问卷，疗效的主要终点为 8 周（治疗结束）和 14 周（随访）后。为了安全起见和研究目的，将反复采集血液化学物质。结果将使用适当的方差分析模型或混合模型进行分析，具体取决于 HD：CAS 的分布和缺失数据的程度。
瑞典伦理审查局和瑞典药品管理局分别于 2020 年 5 月 27 日和 6 月 4 日批准了该研究（编号分别为 2020-02069 和 5.1-2020-48282）。研究结果将发表在同行评议的期刊上，并在相关会议上展示。
2019-004255-36。
