A Randomized, Double-Blind, Placebo-Controlled Medication Trial With D-Cycloserine for Individuals With OCD Currently Receiving Behavior Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Yale-Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).
详细描述
We hope to enroll 50 subjects in a double-blind, placebo-controlled study of D-cycloserine augmentation of behavior therapy for Obsessive-Compulsive Disorder. All subjects will undergo a pre-treatment assessment, and then be randomly assigned to receive Seromycin (100 mg) or placebo one-hour before each of 10 therapy sessions. Subjects will then come in for a treatment planning session and the behavior therapy sessions delivered twice weekly for 5 weeks. Comprehensive assessments of obsessive-compulsive symptoms, mood state, and cognitions will be given at baseline, after 5 treatment sessions, after 10 sessions and 1 month and 6 months post-treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Structured Clinical Interview for DSM-IV (SCID) diagnosis of Obsessive Compulsive Disorder
- •Score of greater than 16 on the Yale-Brown Obsessive Compulsive Scale
- •Negative urinary beta-Human Chorionic Gonadotropin (hCG) test
排除标准
- •Currently taking or have taken an unstable dose of psychotropic medications within 2 months prior to enrollment
- •Currently taking medications that may interfere with the study medication
- •History of seizure disorder or other serious medical illnesses (e.g., cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or blood-related disease)
- •Current diagnosis of tuberculosis
- •Other psychiatric diagnoses (e.g., alcohol dependence, bipolar disorder, psychosis, organic mental disorder, or development disorder) that are of greater concern than the obsessive-compulsive disorder diagnosis
- •Currently taking medications that may lower seizure threshold (e.g., including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem)
- •Poses a serious suicidal or homicidal threat
- •Currently undergoing psychotherapy
- •Failure to benefit from ten or more sessions of previous Exposure and Response Prevention (ERP) treatment
- •Pregnant or breastfeeding
研究组 & 干预措施
Seromycin
干预措施: seromycin (Drug)
Seromycin
干预措施: Behavior Therapy (Behavioral)
Placebo
干预措施: Behavior Therapy (Behavioral)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale (YBOCS)
时间窗: Post-treatment (week 5)
A clinician-rated measure of obsessive-compulsive disorder severity. Each item is scored on a 0 to 4 range. Total scores are obtained by summing items 1-10 and thus range from 0 to 40 with higher scores indicating greater symptom severity. Results posted below are from the post-treatment evaluation (after 10 treatment sessions).
次要结局
- Beck Depression Inventory (BDI)(Post-treatment (week 5))
- Clinical Global Impressions Scale (CGI)(Post-treatment (week 5))
- Beck Anxiety Inventory (BAI)(Post-treatment (week 5))
- Obsessional Beliefs Questionnaire (OBQ)(Post-treatment (week 5))
- Short-Form Health Survey (SF-36)(Post-treatment (week 5))
- Disability Inventory(Post-treatment (week 5))
研究者
Sabine Wilhelm
Director
Massachusetts General Hospital