NCT03349528Enrolling By Invitation2 期
A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Bipolar Depression
Sheppard Pratt Health System2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年12月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Time to Relapse
研究概览
简要总结
The purpose of this study is to determine if taking a probiotic supplement versus a placebo will reduce relapse and improve the clinical course among participants who have been hospitalized for bipolar depression.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 (inclusive)
- •Capacity for written informed consent
- •Currently (or within the last 3 weeks) admitted to a Sheppard Pratt inpatient or day hospital program for symptoms of a depressive episode and a diagnosis Bipolar Disorder I or II, most recent episode depressed per Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5), the diagnosis of which is confirmed with the Structured Clinical Interview for DSM-5 Disorders (SCID-5)
- •Proficient in the English language
- •Available to come to Sheppard Pratt Towson for study visits after hospital discharge
排除标准
- •Depressive symptoms better accounted for by a diagnosis of Major Depressive Disorder, Schizoaffective disorder, Schizophrenia, or disorder(s) other than Bipolar Disorder I or II
- •DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous version of the DSM
- •Substance- or medically-induced mood symptoms at time of Visit 1/Baseline visit
- •DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within three months prior to the Visit 1/Baseline visit
- •History of IV drug use
- •Any clinically significant or poorly controlled medical disorder as determined by the principal investigator and/or the study physician (e.g., HIV infection or other immunodeficiency condition, uncontrolled diabetes, congestive heart failure)
- •A serious medical condition that affects brain or cognitive functioning (e.g., epilepsy, serious head injury, concussion involving loss of consciousness, brain tumor, or other neurological disorder)
- •Pregnant, planning to become pregnant, or breastfeeding during the study period
- •Documented celiac disease
- •Participated in any investigational drug trial in the 30 days prior to the Visit 1/Baseline visit
- •Receipt of Electroconvulsive therapy (ECT) in the 30 days prior to the Visit 1/Baseline visit or planned ECT after hospital discharge
结局指标
主要结局
Time to Relapse
时间窗: Weeks 0 - 24 of study participation
Time to relapse defined as time until psychiatric rehospitalization during the study period
次要结局
- Montgomery-Åsberg Depression Rating Scale (MADRS)(Weeks 0 - 24 of study participation)
- New Mood Episodes(Weeks 0 - 24 of study participation)
- Hamilton Depression Rating Scale(Weeks 0 - 24 of study participation)
- Young Mania Rating Scale(Weeks 0 - 24 of study participation)
- Columbia-Suicide Severity Rating Scale(Weeks 0 - 24 of study participation)
- Brief Psychiatric Rating Scale(Weeks 0 - 24 of study participation)
研究者
Faith Dickerson
Principal Investigator, Stanley Research Program
Sheppard Pratt Health System
研究点 (2)
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