NCT06557525招募中1 期
Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)
UNB Sumiyoshi Jinja Mae Clinic2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- HAMD21 change after intervention
研究概览
简要总结
This is an exploratory study to test the efficacy of a novel EEG neurofeedback method in depressed patients. The investigators will measure the change in depressive symptoms before and after the intervention of the novel EEG neurofeedback method using the Depression Rating Scale (primary endpoint). In addition, The investigators will measure the changes in brain activity before and after the intervention using fMRI, and compare the changes in depressive symptoms over the treatment period (secondary endpoint).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adults (at least 18 years old at the time consent is obtained)
- •2. Major depressive episode as defined by the diagnostic criteria of the DSM 5
- •3. One of the following
- •Hamilton Depression Rating Score (HDRS 17) of 19 or higher
- •Montgomery Asberg Depression Rating Scale score of 20 or higher
- •Any other patient deemed appropriate by the PI (subprincipal investigator)
- •4. With respect to taking antidepressants, any of the following
- •not taking antidepressants
- •If taking antidepressants, willingness to continue them for the duration of the program.
- •5. If receiving psychotherapy, agree to continue the same psychotherapy for the duration of study participation
- •6. Have treated by a psychiatrist
- •7. Written informed consent
- •8. No planned change in employment status after the study begins
排除标准
- •1. High risk of suicide, such as suicidal ideation or suicide attempts
- •2. History of hospitalization for depression or suicidal behavior
- •3. Comorbid addictions (drugs, alcohol) or history of addictions
- •4. Organic brain disease (e.g., moderate or severe intracranial organic lesions or neurodegenerative disease)
- •5. History of seizures or epilepsy
- •6. Has a serious or unstable physical disease
- •7. Difficulty or inappropriateness/contraindication to MRI imaging
- •8. Pregnant women or unwilling to practice contraception during the study
- •9. Participating in another clinical trial at the same time, or have participated in a clinical trial within the past 90 days, or are scheduled to participate in another clinical trial during the study period, and the principal (sub)investigator determines that participation in another clinical trial may interfere with the results of this study
- •10. Other cases in which the principal investigator (or subinvestigator) determines that it is difficult to conduct this study safely.
结局指标
主要结局
HAMD21 change after intervention
时间窗: 4 weeks after the start of the intervention
HAMD21(Hamilton Depression Rating Scale, 21-item version) score change compared to baseline.
次要结局
- HAMD21 remission rate(8 weeks after the start of the intervention)
- HAMD21 compared to baseline(2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention)
- changes in brain activity(2 and 4 weeks after the start of the intervention)
- MADRS compared to baseline(2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention)
- HAMD21 response rate(8 weeks after the start of the intervention)
- PHQ-9 score(2 and 4 weeks after the start of the intervention and at 4, 12, and 24 weeks after the end of the intervention)
- SDS compared to baseline(2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention)
- HAMD21 after intervention(4 weeks after the start of the intervention)
- MADRS after intervention(4 weeks after the start of the intervention)
- duration of remission after the end of the intervention(up to 24 weeks after the end of the intervention)
- Quality of life assessment (EQ-5D-3L)(2 and 4 weeks after the start of the intervention and at 4, 12 and 24 weeks after the end of the intervention)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
1 期
Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)D003863DepressionJPRN-jRCTs032230463Oribe Naoya30
终止
不适用
Neurofeedback In Treatment Resistant DepressionNeurofeedbackDepressionNCT04078438Yeungnam University Hospital70
Unknown
不适用
Efficacy of Electroencephalography (EEG) Neurofeedback (NF) for the Treatment of Anxiety DisorderHealthyAnxiety DisorderNCT04562324Tianjin Anding Hospital60
已完成
1 期
Effectiveness of Brainwave Biofeedback in the Treatment of FibromyalgiaFibromyalgiaNCT00080184National Center for Complementary and Integrative Health (NCCIH)40
已完成
不适用
The Therapeutic Efficacy of Neurofeedback in DepressionDepressionNCT00729547Korea University24