Fluoxetine/Dextromethorphan in Obsessive-Compulsive and Related Disorders: an Open-Label Crossover Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in OCD or related disorder symptoms as measured by the Y-BOCS
研究概览
简要总结
The purpose of the study is to assess the tolerability and efficacy of dextromethorphan in combination with fluoxetine for symptom relief in OCD and related disorders.
详细描述
Obsessive compulsive disorder (OCD) and the related disorders body dysmorphic disorder (BDD), somatic symptom disorder (SSD) and illness anxiety disorder (IAD) are psychiatric conditions characterized by recurrent, intrusive thoughts, feelings or images (obsessions or preoccupations) and repetitive or ritualized behaviors or avoidance performed to relieve obsession or preoccupation-related anxiety. They are a significant cause of mental health-related disability, and are inadequately served by available treatments.
This study tests whether an over-the-counter cough suppressant medicine, dextromethorphan, may offer symptom relief when combined with a low dose of fluoxetine, a standard prescription treatment for OCD and related disorders.
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
- Single (Outcomes Assessor)
盲法说明
Symptom rating will be done by independent evaluators blind to treatment allocation.
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
- •Diagnosis of obsessive-compulsive disorder (OCD), body dysmorphic disorder (BDD), illness anxiety disorder (IAD) or somatic symptom disorder (SSD)
- •Living within California
- •Capacity to provide informed consent
排除标准
- •Current bipolar disorder or psychotic disorder
- •Active moderate or severe substance use disorder, lifetime severe substance use disorder
- •Pregnant or nursing women
- •Use of prescribed psychotropic medications other than fluoxetine for 2 weeks prior to study start
- •Having commenced OCD-targeted exposure and response-prevention (ExRP) psychotherapy within 2 months of study start
研究组 & 干预措施
Group B: fluoxetine plus dextromethorphan then fluoxetine
Group B participants will take fluoxetine 20mg (or prior dose) daily together with over the counter dextromethorphan, with doses increasing weekly as tolerated, for 4 weeks, and then will stop dextromethorphan, continuing fluoxetine alone for 4 weeks.
干预措施: Fluoxetine (Drug)
Group B: fluoxetine plus dextromethorphan then fluoxetine
Group B participants will take fluoxetine 20mg (or prior dose) daily together with over the counter dextromethorphan, with doses increasing weekly as tolerated, for 4 weeks, and then will stop dextromethorphan, continuing fluoxetine alone for 4 weeks.
干预措施: Dextromethorphan (Drug)
Group A: fluoxetine then fluoxetine plus dextromethorphan
Group A participants will take fluoxetine 20mg (or prior dose) daily for 4 weeks, and will then continue fluoxetine while adding over the counter dextromethorphan, with doses increasing weekly as tolerated, for 4 weeks.
干预措施: Fluoxetine (Drug)
Group A: fluoxetine then fluoxetine plus dextromethorphan
Group A participants will take fluoxetine 20mg (or prior dose) daily for 4 weeks, and will then continue fluoxetine while adding over the counter dextromethorphan, with doses increasing weekly as tolerated, for 4 weeks.
干预措施: Dextromethorphan (Drug)
结局指标
主要结局
Improvement in OCD or related disorder symptoms as measured by the Y-BOCS
时间窗: Change from baseline will be assessed at 4 weeks and at 8 weeks.
Improvement in OCD severity is measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a gold standard measure of the severity of obsessions and compulsions. Variants of the Y-BOCS designed for assessment of body dysmorphic disorder or illness anxiety disorder/somatic symptom disorder will be used as appropriate. Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of symptoms. Response will be defined as a 35% reduction in Y-BOCS score.
次要结局
- Improvement in clinical insight as measured by the BABS(Change from baseline will be assessed at 4 weeks and at 8 weeks.)
研究者
Peter J van Roessel, MD PhD
Clinical Associate Professor
Stanford University