Intensive Transcranial Direct Current Stimulation in the Treatment of Major Depression: Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
This will be a prospective, open-label, single-arm study to determine the safety and feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for major depressive disorder (MDD). Participants will be age 18-65 with a diagnosis of unipolar MDD. Participants will receive an intensive treatment of tDCS over a 10-day treatment period and complete follow-up assessments at the end of treatment, 1, and 4 weeks post-treatment.
详细描述
This will be a prospective, open-label, single-arm study to determine the safety and feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for major depressive disorder (MDD). Secondary objective is to gather preliminary data on the clinical effects of the protocol. After assessment and inclusion into the study, participants will receive up to 50 tDCS sessions over 10 days.
Study procedures:
Daily assessments: brief questions before and after each tDCS session to evaluate potential adverse events as well as a verbal rating scale for pain.
Questionnaires : a battery of mood questionnaires will be completed to inform findings regarding clinical effects of the treatment.
Cognitive measures: a short cognitive assessment will be completed to inform findings regarding cognitive safety of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Diagnosis of Major unipolar depression for at least 4 weeks meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)
- •Age between 18 to 65
- •Minimum score of 17 on the GRID-Hamilton Depression Rating Scale (GRID-HAMD)
排除标准
- •Bipolar disorder,
- •Psychosis
- •Active substance use disorder (in the last 3 months)
- •Personality disorder
- •Neurocognitive disorder
- •High risk of suicide
- •Major comorbid medical or neurological condition
- •Pregnancy
- •Medical contraindications to tDCS:
- •Ferromagnetic material in the skull
- •Defect in the bone substance of the skull
- •Dermatological condition (e.g. eczema, psoriasis, urticaria, dermatitis, acne, hyperhidrosis, folliculitis, rosacea, keratosis, herpes, infectious or neoplastic phenomenon, etc.)
- •Skin lesion on the skull (ex: cuts, abrasions, rash, tattoos on the skull, piercings on the head, etc.)
结局指标
主要结局
Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9)
时间窗: T0 (baseline), T1 (1 week after end of treatment) and T2 (one month after the end of the treatment)
This outcome reflects the percentage change in depressive symptom severity as measured by the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale assessing depressive symptoms over the past 2 weeks. Each item is scored from 0 ("Not at all") to 3 ("Nearly every day"), with a total score ranging from 0 to 27. Higher scores indicate more severe depression. Percentage change from baseline (T0) was calculated at two follow-up timepoints: * T1 = 1 week after end of treatment (Day 17) * T2 = 1 month after end of treatment (Day 40) Percentage change was calculated using the formula: ((T\_follow-up - T0) / T0) × 100. A negative value indicates improvement.
次要结局
未报告次要终点