A Pilot Study Examining the Gut Microbiota in Patients With Obsessive-Compulsive Disorder vs. Healthy Controls and Following 12-weeks of Open-label Selective Serotonin Reuptake Inhibitors Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale
研究概览
简要总结
This study will examine the gut microbiota and serum inflammatory markers in patients with Obsessive-Compulsive Disorder vs. healthy controls. Phase II of the study will examine the gut microbiota and cytokine levels following 12-weeks of treatment with Selective Serotonin Reuptake Inhibitors (SSRIs).
详细描述
Phase I of the study will involve 25 healthy controls (no anxiety or mood disorders) and 25 outpatients with primary DSM 5 OCD. Participants ages 18-65 will be assessed using the Mini International Neuropsychiatric Interview (MINI) to determine whether criteria for a primary OCD diagnosis is met alongside any additional comorbid disorders. Healthy controls will also be assessed using the MINI to confirm the absence of any psychiatric disorders. Participants will complete a number of clinician and self-rated symptom severity scales as listed below:
a. Yale Brown Obsessive-Compulsive Scale (YBOCS) - Clinician-rated b. Montgomery Asberg Depression Rating Scale (MADRS) - Clinician-rated c. Obsessive-Compulsive Inventory - Revised (OCI-R) - Self-rated d. Depression Anxiety Stress Scale (DASS-21) - Self-rated e. Dutch Dimensional Obsessive-Compulsive Scale (DDOCS) - Self-rated
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They will also complete additional questionnaires pertaining to their diet and bowel functioning:
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Gastrointestinal Symptom Rating Scale (GSRS)
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Short-form Leeds Dyspepsia Questionnaire (SF-LDQ)
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Rome III criteria for Irritable Bowel Syndrome
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Assessment of diet using the Anti-Cancer Council of Victoria Food Frequency Questionnaire (ACCVFFQ).
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Subjects will also be asked to provide background information regarding travel in the past 4 months and current place (and duration) of residence as these factors may potentially affect the microbiome profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- 是
入选标准
- •Patients with a primary diagnosis of OCD (DSM 5) according to the MINI
- •Y-BOCS score of ≥
- •MADRS < 18
排除标准
- •Participants with current Major Depressive Disorder.
- •Patients with significant suicidal ideation (MADRS item 10 ≥ 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- •Individuals with current autoimmune disorders (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.), inflammatory bowel disease, diabetes.
- •Current use of any psychotropic agent SSRIs, benzodiazepines, MAO Inhibitors, tricyclic antidepressants. Past pharmacotherapy is permitted if treatment ended 3 months prior to sampling.
- •Current use of herbal psychoactive treatments i.e. St. John's Wort, Kava Kava, Chamomile Extract, Valeria. Past use is permitted if treatment ended 3 months prior to sampling.
- •Participants receiving current psychotherapy, including cognitive behavioural therapy for an anxiety or mood disorder 3 months prior to sampling.
- •Patients who currently fulfill criteria for a lifetime history of bipolar disorder, history of drug abuse, a history of schizophrenia or other psychotic disorders, delirium, dementia and amnesic and other cognitive disorders, or are in a current agitated state.
- •Patients meeting criteria for current substance use disorder.
- •A body mass index (BMI) >30
- •Antibiotic or probiotic use within 8 weeks of sampling. Patients beginning antibiotic treatment or probiotic use during Phase II of the study will be excluded.
研究组 & 干预措施
SSRI treatment
The intervention only applies to Phase II of the proposed study. Individuals in the OCD group will be offered 12-weeks of standard SSRI treatment ti determine whether 12-weeks of treatment results in a change of the gut microbiota/inflammatory markers.
干预措施: SSRIs (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale
时间窗: 12 weeks
Clinical Global Impression - Improvement
时间窗: 12 weeks
次要结局
- Dutch Dimensional Obsessive Compulsive Scale (DDOCS)(12 weeks)
- Depression Anxiety Stress Scale (DASS-21)(12 weeks)
- Obsessive-Compulsive Inventory - Revised (OCI-R)(12 weeks)
- Anti-Cancer Council of Victoria Food Frequency Questionnaire(12 weeks)