Clinical, Neurocognitive and Neuroimaging Variables Associated With Response to Treatment in Patients With OCD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- level of improvement
研究概览
简要总结
This study consists of a naturalistic follow-up of subjects with Obsessive-Compulsive Disorder (OCD) that have participated in a global study investigating brain signatures of OCD funded by the National Institutes of Mental Health (RO1MH113250), with the following participant sites: the US (Columbia University, PI: Helen Blair Simpson), Brazil (University of Sao Paulo, PIs: Euripedes Miguel and Roseli G Shavitt), India (National Institutes of Mental Health, PI: Janardhan Reddy), The Netherlands (VU Amsterdam Medical Center, PI: Odile van den Heuvel), and South Africa (University of Cape Town, PI: Dan Stein; Stellenbosch University, PI: Christine Lochner). In this cross-sectional study, two-hundred and fifty unmedicated subjects with OCD (50 per site) will be assessed for clinical, neurocognitive and neuroimaging data. After completion of this study, participants willing to receive evidence-based treatments for OCD will be treated with the available resources in each site and will be assessed for treatment response status periodically, with a final assessment after 1 year of naturalistic follow-up. At this point, we will investigate baseline clinical, neurocognitive and neuroimaging variables associated with the treatment response status.
详细描述
This study aims to investigate clinical, neurocognitive and neuroimaging variables associated with response to conventional treatments in adults with OCD.
Study design:
- 0-52 weeks: open-label trial of a selective serotonin reuptake inhibitor (SSRI) (preferably sertraline - easily available in the public network, usually well tolerated) up to the maximum recommended or tolerated dose (e.g., titration: start with 50mg/day, then add 50mg/day per week up to 200mg/day, if sertraline); patients who prefer to be treated with cognitive-behavioral therapy (CBT) will be given this option whenever CBT is available.
- treatment will be delivered under naturalistic conditions, tailored according to the needs, preference, and availability. Subjects will be called up for follow-up assessments at 3, 6, 9 and 12 months after baseline assessments. The instruments to be used at follow-up are the YBOCS and CGI scales.
- Response criteria: the definitions of a recent international expert consensus will be adopted (Mataix-Cols. et al., 2016). A positive response will be considered as at least 35% reduction in baseline Yale-Brown Obsessive-Compulsive Scale (YBOCS) scores plus a Clinical Global Impression-Improvement (CGI-I) rating of 1 ("very much improved") or 2 ("much improved"), lasting for at least one week. We will also rate the CGI - severity. Partial response will correspond to a greater than 25% but less than 35% reduction in Y-BOCS scores plus a CGI-I rating of at least 3 ("minimally improved"), lasting for at least one week.
Subjects:
• All participants assessed for clinical, neurocognitive and neuroimaging data in the global brain signatures study who are willing to receive evidence-based treatment for OCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Principal DSM-5 diagnosis of OCD
- •Y-BOCS ≥ 16
- •No psychotropic meds for the last 6 weeks, with the exception of PRN sleeping meds (e.g., zolpidem or trazodone up to 50 mg) and benzos, as long as not within the past week or during study participation
- •No CBT/EXRP focused on OCD within the past 6 weeks
- •Capable of providing informed consent
排除标准
- •Lifetime diagnosis of psychotic disorder, bipolar disorder, anorexia nervosa, autism spectrum disorder with IQ < 80, Tourette Disorder
- •Current chronic tic disorder (current = in the past 12 months)
- •Current substance-related and addictive disorders, including nicotine (current = in the past 12 months)
- •Current binge-eating disorder or bulimia (current = in the past 12 months)
- •Acute risk of suicide
- •Female who is pregnant
- •Major medical or neurological problems (including head injury with loss of consciousness) Presence of metallic devices or dental braces
- •Cigarette use: more than 5 per day
- •Alcohol use: more than 2 drinks per day for women and more than 3 drinks per day for men, Marijuana use: more than once per week
研究组 & 干预措施
SSRI or cognitive behavioral therapy
selective serotonin reuptake inhibitors (fluoxetine, sertraline, citalopram, escitalopram, paroxetine or fluvoxamine) or cognitive-behavioral therapy, depending on availability and patient preference
干预措施: selective serotonin reuptake inhibitor (Drug)
结局指标
主要结局
level of improvement
时间窗: 12 months
measured by the Clinical Global Impression Scale - severity and improvement subscales. The severity subscale can be rated from 1 to 7, a higher score corresponding to more severe symptoms. The improvement subscale can also be rated from 1 to 7, a greater score corresponding to lesser improvement. Scores are given individually to each subscale, in absolute numbers (1 to 7)
response status
时间窗: 12 months
severity of OCD as measured by the Yale-Brown Obsessive-Compulsive Scale. The final score of this scale is a sum of 10 items, ranging from 0 to 40. The higher the score, the more severe the clinical picture. The ten items refer to ten questions, five regarding obsessions and five regarding compulsions. The questions assess time, distress, interference, resistance and control over the symptoms. Each question can be rated from 0 (= none) to 4 (most severe).
次要结局
未报告次要终点
研究者
Roseli Gedanke Shavitt
Director, Obsessive-Compulsive Spectrum Disorders Program, Institute of Psychiatry, Hospital of Clinics, University of Sao Paulo School of Medicine
University of Sao Paulo