Tolcapone Treatment of Obsessive Compulsive Disorder: A Double-Blind, Placebo-Controlled, Cross-Over Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale (Y-BOCS)
研究概览
简要总结
The proposed study will consist of a 5-week double-blind cross-over study trial of tolcapone in 20 people (ages 18-65). The study will be divided into an initial 2 week phase and a second 2 week phase, with one of the 2 week phases consisting of active treatment with tolcapone, and the other 2 week phase consisting of inactive placebo treatment. There will be a one-week wash-out phase between the 2-week treatment phases. Participants will be randomized to receive either tolcapone or placebo during the first 2 week phase on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.
详细描述
The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in adults with obsessive compulsive disorder (OCD). The hypothesis to be tested is that tolcapone will be more effective and well tolerated in adults with OCD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder where current treatments are often ineffective.
The primary aim of this application is to conduct a randomized placebo-controlled pharmacotherapy trial using tolcapone in 20 participants with OCD. The study will consist of two phases: a 2 week active treatment phase with tolcapone, a one-week wash-out phase, and a 2 week placebo phase. The subjects will be randomized to either receive tolcapone or placebo treatment in the first 2 weeks, and the other during the remaining 2 week phase.
This will be one of few studies assessing the use of pharmacotherapy for the treatment of OCD in adults. Assessing the efficacy and safety of tolcapone will help inform clinicians about additional treatment options for adults suffering from this disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females age 18-65;
- •Diagnosis of current OCD based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);
- •Able and willing to provide written consent for participation.
排除标准
- •Unstable medical illness, including liver disease, as determined by the investigator;
- •History of seizures;
- •Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);
- •Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS);
- •Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder;
- •Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
- •Previous treatment with tolcapone;
- •Any history of psychiatric hospitalization in the past year;
- •Currently pregnant (confirmed by urine pregnancy test)
研究组 & 干预措施
Tolcapone
Each subject will have a 4 week treatment phase with Tolcapone
干预措施: Tolcapone 200 MG (Drug)
Placebo
4 week placebo phase before or after Tolcapone phase depending on randomization.
干预措施: Tolcapone 200 MG (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
时间窗: 2 weeks (start of study to washout period OR two weeks following washout period)
The entire study for the subject will last 5 weeks. Every 2 weeks and after the one week washout period the subject will take the YBOCS. The change in scores from baseline to after 5 weeks will be assessed. The scale itself assesses severity of OCD symptoms. The YBOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.
次要结局
- Hamilton Depression Rating Scale (HAM-D)(2 weeks (start of study to washout period OR two weeks following washout period))
- Sheehan Disability Scale (SDS)(2 weeks (start of study to washout period OR two weeks following washout period))
- Hamilton Anxiety Rating Scale (HAM-A)(2 weeks (start of study to washout period OR two weeks following washout period))
- Clinical Global Impression- Severity and Improvement (CGI)(2 weeks (start of study to washout period OR two weeks following washout period))