rTMS Over the Supplementary Motor Area for Treatment-resistant Obsessive-compulsive Disorder: a Multicenter, Double-blind, Controlled Trial.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- rTMS effects on OC symptoms
研究概览
简要总结
The aim of this study is to investigate the effectiveness of low-frequency (1Hz) rTMS (repetitive transcranial magnetic stimulation) over the pre-SMA (pre-supplementary motor area) in a sample of treatment-resistant OCD patients in a multicenter, controlled design.
详细描述
N consecutive treatment-resistant OCD outpatients, fulfilling all the inclusion criteria, will be recruited by each center involved in the study.
To be included in the study all the patients must be aged between 18 and 65 yy and have to meet DSM-5 criteria for OCD with a Y-BOCS total score > or = 20 and a history of treatment-resistant OCD, established by a trained psychiatrist with extensive expertise in the OCD field. Treatment-resistance is defined as non-response (less than 25% reduction of the Y-BOCS score) after at least one SRIs trials (clomipramine, fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram) at the maximum tolerable dose for at least 12 weeks. Potential patients with any of the following conditions will be excluded: 1) any additional current psychiatric comorbidity, except for mild depressive and anxious symptoms or tics; 2) a lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition; 3) serious suicide risk; 4) episodic OCD; 5) illness duration less than two years; 6) hospitalization in the last 6 months; 7) refractory OCD (defined as non response to two SRIs trials, one antidopaminergic augmentation and at least one CBT with ERP trial); 8) patient who did not response to a previous ECT trial; 9) the inability to receive rTMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives); 10) any major medical disease; 11) pregnancy or nursing of an infant; 12) the inability or refusal to provide written informed consent.
No psychotherapy and/or pharmacological treatments changes will be allowed during the study period. Pharmacologically treated patients should be on constant medications for at least 6 weeks before entering the study.
Female patients included in the study will not be required to adopt contraceptive measures.
Patients with prior TMS exposure will be excluded in order to reduce the risk of unblinding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, the investigators and the outcome assessor will be blind to the type of intervention (TMS or SHAM). The TMS operator will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 65 yy
- •DSM-5 criteria for OCD
- •Y-BOCS total score > or = 20
- •History of treatment-resistant OCD, established by a trained psychiatrist with extensive expertise in the OCD field. Treatment-resistance is defined as non-response (less than 25% reduction of the Y-BOCS score) after at least one SRIs trials (clomipramine, fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram) at the maximum tolerable dose for at least 12 weeks.
排除标准
- •any additional current psychiatric comorbidity, except for mild depressive and anxious symptoms or tics;
- •a lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition;
- •serious suicide risk;
- •episodic OCD;
- •illness duration less than two years
- •hospitalization in the last 6 months;
- •refractory OCD (defined as non response to two SRIs trials, one antidopaminergic augmentation and at least one CBT with ERP trial);
- •patient who did not response to a previous ECT trial;
- •the inability to receive rTMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives);
- •any major medical disease;
- •pregnancy or nursing of an infant;
- •the inability or refusal to provide written informed consent.
结局指标
主要结局
rTMS effects on OC symptoms
时间窗: end of the study
Standard criteria for the treatment outcome will be included in the trial: response (\>35% improvement in baseline Y-BOCS scores and a CGI-I of 1 or 2), partial response (≥ 25% improvement in baseline Y-BOCS scores), and non-response (\<25% improvement in baseline Y-BOCS scores).
次要结局
未报告次要终点