NCT05384041已完成不适用
Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults
Fisher Wallace Laboratories1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2022年4月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline.
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of the Fisher Wallace Stimulator FW-200 to deliver Cranial Electrotherapy Stimulation (CES) for the treatment of moderate to severe Major Depressive Disorder (MDD) in adults.
详细描述
This prospective, fully remote, randomized, controlled, triple-blind (subject, Principal Investigator, Sponsor) pivotal study is designed to evaluate the safety and efficacy of the Fisher Wallace Stimulator FW-200 to deliver Cranial Electrotherapy Stimulation (CES) for the treatment of moderate to severe Major Depressive Disorder (MDD) in adults.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Remote, randomized, decentralized, controlled, triple-blind (subject, Principal Investigator, Sponsor) pivotal investigation.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-65 years and a resident of the United States of America
- •Meets DSM-5 diagnostic criteria for moderate to severe Major Depressive Disorder
- •Baseline BDI-II score between 20 and 63, inclusive (in moderate to severe range)
- •Able to receive packages to their home via United Parcel Service/Fedex/United States Postal Service or other delivery service
- •Willing and able to send and receive study related text messages on an internet capable mobile device throughout the duration of the study
- •Owns and uses a personal, verifiable email address
- •Able to commit to two (2) 20-minute treatment sessions per day for 4 weeks, one treatment upon waking for the day and one treatment before going to bed
- •Willing to abstain from use of recreational drugs, hypnotics, steroids, and/or marijuana products through study completion
- •Willingness to not initiate treatment for a mental health issue during the course of the study
- •Fluent in English
- •Sexually active females of childbearing potential willing to commit to practicing at least one or more of the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception, or abstinence
- •In the opinion of the investigator, able to comply with study requirements and complete the study
排除标准
- •History of suicide attempt or active suicidal ideation with plan or intent in the past 30 days.
- •In the opinion of the investigator, considered high risk of suicide
- •Previous hospitalization or institutionalization for mental health condition within one year of study entry
- •Underwent electronic brain stimulation or neuromodulation within the past one year, including CES, transcranial magnetic stimulation, electroconvulsive therapy, and deep brain stimulation
- •Modification of prescription medications that affect the nervous system (e.g., psychotropic medications) within 30 days of study entry
- •Use of recreational drugs, hypnotics, steroids, and/or marijuana products in the past 30 days
- •History of alcohol use disorder or other substance use disorder in the past 12 months
- •Females currently pregnant or planning to conceive during study participation, or unwilling to comply with birth control requirements
- •Known history of heart disease
- •Known history of trigeminal neuralgia
- •Implanted with an electronic device such as a defibrillator, deep brain stimulator, or pacemaker
- •Unstable medical condition including any condition requiring hospitalization or change in treatment in the prior 30 days
- •Legally blind and/or deaf and without in-home care service to assist with study participation
- •Meets M.I.N.I. assessment criteria for, or has been diagnosed with, any of the following: Bipolar I disorder, bipolar II disorder, other specified bipolar and related disorder, panic disorder, agoraphobia, social anxiety disorder (social phobia), obsessive-compulsive disorder, posttraumatic stress disorder, alcohol use disorder in the past 12 months, substance use disorder (non-alcohol) in the past 12 months, any psychotic disorder (e.g., schizophrenia, schizoaffective disorder), major depressive disorder with psychotic features, anorexia nervosa, bulimia nervosa, binge-eating disorder, generalized anxiety disorder, any cognitive or developmental disorder (e.g., autism, Down's Syndrome), any personality disorder or psychiatric disorder that may interfere with study participation
- •Current participation in another investigational study or participated in an investigational study within the past 30 days
- •In the opinion of the investigator, may not be able to comply with study requirements
- •Any employee, family member, or personal associate of the Sponsor or their designees conducting the study
结局指标
主要结局
Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline.
时间窗: Change at week two compared to baseline.
The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms. The candidate subject's BDI-II score must be within the range of 20 to 63 indicating moderate to severe Major Depressive Disorder.
次要结局
- Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline.(Change at weeks one and four compared to baseline.)
- Change in the Patient Health Questionnaire-9 (PHQ-9) at Weeks One, Two, and Four Compared to Baseline.(Change at weeks one, two, and four compared to baseline.)
- Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at Weeks One, Two, and Four Compared to Baseline.(Change at weeks one, two, and four compared to baseline.)
- Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline).(Four weeks following baseline.)
研究者
研究点 (1)
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