Maximizing Treatment Outcome in OCD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
研究概览
简要总结
This study will compare the short- and long-term effectiveness of two common therapies in improving serotonin reuptake inhibitor treatment in people with obsessive-compulsive disorder.
详细描述
Obsessive-compulsive disorder (OCD) is a common psychiatric illness. People with OCD experience unwelcome thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. Impairment due to OCD symptoms ranges from mild to severe, and sometimes can be disabling. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Cognitive-behavioral therapy (CBT), a talking therapy that focuses on altering a person's thoughts and behaviors, and the medication risperidone have both been commonly used for augmenting SRI treatment for OCD. This study will compare the short- and long-term effectiveness of exposure and ritual prevention (EX/RP), a type of CBT, and risperidone in augmenting SRI treatment in people with OCD.
Participants in this double-blind study will be randomly assigned to receive EX/RP, risperidone, or placebo in conjunction with their regular SRI medication. All participants will remain on their regular SRI at a stable dose. During the first 2 months of the study, participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response. Participants assigned to risperidone or placebo will meet with a psychiatrist once every 1 to 2 weeks. At the end of 8 weeks, all participants' OCD symptom severity will be assessed. During this time, participants who have responded to treatment will continue receiving the same treatment for an additional 24 weeks. Participants assigned to EX/RP will meet with a therapist no more than 15 times total, and participants receiving risperidone or placebo will meet with a psychiatrist once every 4 weeks. Outcomes will be reassessed at study completion.
Ortho McNeil Janssen Scientific Affairs, LLC are providing medication and placebos for this study.
For information on a related study, please follow this link:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of OCD
- •Currently on a stable and adequate dose of an SRI
- •Sufficient severity of symptoms to warrant additional augmentation treatment
排除标准
- •Medical or psychiatric conditions that would make participation in the study unsafe
- •Currently receiving psychotherapy elsewhere at the time of study entry
- •Previously (within 12 weeks prior to study entry) attended 8 or more sessions of EX/RP within a 2-month period or received at least 4 weeks of antipsychotic augmentation while on an adequate SRI dose
- •Currently being treated with an SRI for the first time and has not yet responded, but has not tried another SRI
研究组 & 干预措施
1
Participants will receive treatment with risperidone
干预措施: Risperidone (Drug)
2
Participants will receive exposure and ritual prevention therapy (EX/RP)
干预措施: Exposure/ritual prevention therapy (EX/RP) (Behavioral)
3
Participants will receive treatment with the placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
时间窗: Week 0 and Week 8
Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity
次要结局
- Social Adjustment Scale-SR(Week 0 and Week 8)
- Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form(Week 0 and Week 8)
- Hamilton Depression Rating Scale (Ham-D)(Week 0 and Week 8)
- Brown Assessment of Beliefs (BABS)(Week 0 and Week 8)