FROM DISEASE MODELING TO THE MOLECULAR BASES OF TREATMENT RESPONSE FOR OBSESSIVE-COMPULSIVE DISORDER USING INNOVATIVE THERAPIES AND PATIENT-DERIVED PLURIPOTENT STEM CELLS
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score
研究概览
简要总结
This study focuses on people with obsessive-compulsive disorder (OCD) who do not respond well to standard treatments. Researchers aim to understand why some patients respond to medications or brain stimulation therapies, while others do not. The study will include 60 patients grouped by their treatment response:
- Those who respond to medications
- Those who respond to transcranial magnetic stimulation (TMS)
- Those who do not respond to either Blood samples will be used to create nerve cells in the lab, allowing scientists to study how these cells react to treatments and brain stimulation. By combining clinical information with lab findings, the goal is to discover biological markers that predict which therapy will work best for each person. This research hopes to improve personalized treatment options for OCD.
详细描述
Adults (18-65 years old) with obsessive-compulsive disorder (OCD) recruited at two specialized clinics in Milan (Luigi Sacco Hospital) and Monza (IRCCS Fondazione San Gerardo Monza). After a complete explanation of the study, everyone will provide written informed consent and have a diagnostic interview to confirm OCD. People with seizures/epilepsy or certain implanted devices (e.g., pacemaker, intracranial metal clips) will not be enrolled.
Procedures:
- Initial assessments: Participants complete standard questionnaires and tests about OCD symptoms, mood, anxiety, and thinking (e.g., Y-BOCS, HDRS, HARS, MMSE, CANTAB, CGI). Basic information (age, sex, education, medical history, current medications) is collected in an anonymized electronic form.
- Grouping by medication response:
Responders (20 people): OCD symptoms improve with serotonin reuptake inhibitors (SRIs).
Treatment-resistant (40 people): OCD symptoms did not improve after multiple SRI trials (including SSRIs and clomipramine at recommended doses). 3. Randomized brain stimulation for treatment-resistant OCD:
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
- None
盲法说明
This is an open-label study with no masking. Participants, care providers, and investigators are aware of the assigned intervention (TBS or d-TMS), as the procedures differ in administration and cannot be feasibly blinded. No independent blinded outcome assessors are used.
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
- •diagnosis of Obsessive-Compulsive Disorder (according to DSM-5; APA, 2013); both sexes; age ≥ 18 years and ≤ 65 years, ability to provide valid written informed consent; for patients classified as responders to pharmacological treatment, a clinical history of at least one pharmacological trial with an SRI for a minimum of 6 weeks and evidence of treatment response, defined as a 30% reduction in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score (Goodman et al., 1989) relative to the patient's baseline; for patients classified as resistant to pharmacological treatment [TR], clear evidence of treatment resistance, defined as the absence of a significant clinical response after at least two treatment trials with selective serotonin reuptake inhibitors (SSRIs) and one trial with clomipramine, each administered for a minimum of 12 weeks at the maximum recommended dose (Pallanti et al., 2002).
排除标准
- •inability to provide informed consent; no clinical history of treatment with SRI medications; clinical history of epilepsy or seizures; presence of a pacemaker, removable metal prostheses, implanted medical pumps, or intracranial metal clips.
结局指标
主要结局
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score
时间窗: Baseline to 10 weeks (end of treatment and follow-up)
The primary outcome is the change in Y-BOCS total score from baseline to the end of treatment, used to assess clinical response to TBS versus d-TMS in treatment-resistant OCD patients.
次要结局
- Clinical response rate(Baseline to end of follow-up (4 weeks post-treatment))
- Change in Clinical Global Impression (CGI) scores(Baseline to 10 weeks)
- Change in Hamilton Depression Rating Scale (HDRS)(Baseline to end of follow-up (4 weeks post-treatment))
- Change in Hamilton Anxiety Rating Scale (HARS)(Baseline to end of follow-up (4 weeks post-treatment))
- Molecular and cellular characterization of patient-derived neurons(From baseline (sample collection) to completion of laboratory analyses (up to 36 months))
- Treatment response classification(Baseline to end of follow-up (4 weeks post-treatment))
研究者
BERNARDO DELL'OSSO
MD, FULL PROFESSOR OF PSYCHIATRY
ASST Fatebenefratelli Sacco