Attaining and Maintaining Wellness in OCD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Obsessive Compulsive Symptom Severity (Y-BOCS)
研究概览
简要总结
The goal of this study is to understand whether patients with obsessive-compulsive disorder (OCD) on serotonin reuptake inhibitors (SRIs) who receive a type of Cognitive-behavioral therapy called Exposure and Ritual Prevention (EX/RP) can discontinue their medication if they first do well with EX/RP.
详细描述
This study begins with a Preparatory Phase, wherein all eligible participants receive up to 25 sessions of Exposure and Ritual Prevention (EX/RP) therapy. At the end of the Preparatory Phase, those who have achieved wellness (mild to minimal symptoms) enter the Study Phase. Those who do not achieve wellness will not continue in the study and are referred for treatment elsewhere. Those who enter the Study Phase are then assigned by chance to one of two groups. One group will continue on the SRI medication and the other group will discontinue the SRI gradually over 4-6 weeks as it is replaced with a placebo (sugar pill). Neither patients nor study staff will know which group a participant is in. Both groups will continue to receive monthly sessions of EX/RP. The study will examine who has the best response to treatment in this study, including taking blood samples for genetic testing to see whether there are genes that can predict who will or will not benefit from EX/RP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preparatory Phase
- •Inclusion Criteria:
- •Primary diagnosis of OCD
- •Currently on a stable and adequate dose of a serotonin reuptake inhibitor (i.e., clomipramine, fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram) but still have clinically significant OCD symptoms
排除标准
- •Comorbid Psychiatric conditions that significantly elevate the risks of study participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or other cognitive disorder, suicidality)
- •Unstable medical conditions that need attention and would make participation in the study unsafe (e.g., very high blood pressure)
- •Patients who have already had prior adjunctive EX/RP (more than 8 sessions within 2 months) while receiving an adequate SRI trial
- •Patients taking other medications besides an SRI (e.g. antipsychotics, mood stabilizers, other antidepressants besides SRIs)
- •Patients who are pregnant, sexually active and not using contraception, or nursing
- •Study Phase
- •Inclusion Criteria:
- •Those who achieve mild to minimum OCD symptoms from Preparatory Phase will enter the Study Phase
- •Exclusion Criteria:
- •All exclusions listed above for Preparatory Phase are exclusions for Study Phase as well
- •Patients who are depressed at the end of the Preparatory phase are excluded from Study Phase
研究组 & 干预措施
Continuation of SRI
Patients who achieve minimal to mild OCD symptoms and are not currently depressed at end of preparatory phase will be randomized to stay on SRI. They will receive 45 minute EX/RP booster sessions once per month.
干预措施: Monthly Booster Sessions of EX/RP (Behavioral)
Continuation of SRI
Patients who achieve minimal to mild OCD symptoms and are not currently depressed at end of preparatory phase will be randomized to stay on SRI. They will receive 45 minute EX/RP booster sessions once per month.
干预措施: Visits with MD and independent evaluators (Procedure)
Replace SRI w/placebo
Patients who achieve minimal to mild OCD symptoms and are not currently depressed at end of preparatory phase will be randomized to gradual replacement with pill placebo. They will receive 45 minute EX/RP booster sessions once per month.
干预措施: Monthly Booster Sessions of EX/RP (Behavioral)
Replace SRI w/placebo
Patients who achieve minimal to mild OCD symptoms and are not currently depressed at end of preparatory phase will be randomized to gradual replacement with pill placebo. They will receive 45 minute EX/RP booster sessions once per month.
干预措施: Visits with MD and independent evaluators (Procedure)
结局指标
主要结局
Obsessive Compulsive Symptom Severity (Y-BOCS)
时间窗: 6 months
In study phase, to determine whether those who have achieved wellness with Cognitive Behavioral Therapy who are on medication can maintain wellness when medication is stopped
次要结局
- Depressive severity (HAMD17)(6 months)
- Quality of Life (QLESQ-S)(6 months)
研究者
Helen Blair Simpson
Professor of Clinical Psychiatry, College of Physicians and Surgeons, Columbia University Director of the Anxiety Disorders Clinic and OCD Research Program, New York State Psychiatric Institute
New York State Psychiatric Institute