Internet-based Cognitive Behavior Therapy in Combination With D-Cycloserine for Obsessive Compulsive Disorder: A Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale (Y-BOCS) (clinician rated)
研究概览
简要总结
The purpose of this study is to examine if D-Cycloserine is an effective adjunct to internet-based cognitive behaviour therapy for patients with obsessive-compulsive disorder.
详细描述
Trial Objectives:
Primary aim is to investigate whether D-Cycloserine gives incremental effects to ICBT in terms of reduced OCD symptoms. Secondary aims are to a) replicate previous findings in that DCS fastens the effects of CBT, b) correlate the fastened effect to overall treatment adherence and c) investigate gene variation and therapeutic factors as predictors of symptom severity, symptom type and treatment response.
Trial Design: Double blinded randomized controlled trial
Dose/Duration: 5 capsules of 50 mg D-Cycloserine or placebo. 1 pcs per week for 5 weeks. All participants also receive Internet-based cognitive behavior therapy for 12 weeks.
Primary Endpoint: Change from W0-W13 and 3-months follow-up.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Male or female
- •≥ 18 years
- •Currently living in Stockholm, Uppland, Örebro, Södermanland, Gästrikland, Västmanland and Östergötland county in Sweden.
- •Primary diagnosis of OCD according to the DSM-IV-TR.
- •Signed informed consent
- •Have regular access to a computer with internet access and skills to use the web
- •Have received information about the need of using contraception
排除标准
- •Pregnancy or breast feeding
- •Patients unlikely to cooperate fully in the study
- •Patients not able to read or understand the basics of the ICBT self-help material
- •Psychotropic medication changes within two months prior to treatment
- •Completed CBT for OCD within last 12 months
- •Y-BOCS [21] < 16 at Psychiatrist visit (6.2.3)pi
- •OCD symptoms primarily associated with hoarding.
- •Other primary axis I diagnosis according to the Mini-International Neuropsychiatric Interview (MINI) [34]
- •Ongoing substance dependence
- •Lifetime bipolar disorder or psychosis
- •Suicidal ideation
- •Axis II diagnosis that could jeopardize treatment participation
- •Serious physical illness that will be an obstacle in ICBT and DCS
- •Other ongoing psychological treatments that could affect OCD symptoms
- •Epilepsia
- •Renal impairment
- •Hypersensitivity to D-Cycloserine
- •Porphyria
- •Chronic Alcoholism
研究组 & 干预措施
D-Cycloserine
D-Cycloserine, 5 pills (50mg), once per week in 5 weeks.
干预措施: D-Cycloserine (Drug)
Placebo
Placebo: 5 pills for 5 weeks, once per week.
干预措施: Placebo (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale (Y-BOCS) (clinician rated)
时间窗: W0,W6,W13. Mid assessments immediately before and after DCS treatment. Long term follow-up at 3-, 12- and 24 months after treatment has ended
Change from Baseline in OCD severity after 12 weeks and at 3-, 12- and 24 months after treatment has ended.
次要结局
- Global assessment of functioning (GAF)(W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended)
- Obsessive Compulsive Scale - Revised (OCI-R)(W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended)
- Clinical global impression (CGI)(W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended)
- Yale Brown Obsessive Compulsive Scale (Y-BOCS)(self-rated)(W0, W1,W2,W3,W4,W5,W6,W7,W8,W9,W10,W11,W12, Long term follow-up at 3-, 12- and 24 months after treatment has ended)
- Montgomery Asberg Depression Rating Scale Self-rating (MADRS-S)(W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended)
- Euroqol(W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended)
- Trimbos and institute of medical technology assessment cost questionnaire for psychiatry (TIC-P)(W0, W13, Long term follow-up at 3-, 12- and 24 months after treatment has ended)
- Adverse events(W0, W1,W2,W3,W4,W5,W6,W7,W8,W9,W10,W11,W12,W13 Long term follow-up at 3-, 12- and 24 months after treatment has ended)
研究者
Christian Rück
MD, PhD
Karolinska Institutet