A Blinded, Randomized Trial Comparing the Effects of Transcranial Magnetic Stimulation and Theta Burst Stimulation in Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Beck Depression Inventory (BDI-II)
研究概览
简要总结
The purpose of this study is to investigate the differences in efficacy between transcranial magnetic stimulation (TMS) and intermittent theta burst stimulation (iTBS) treatment in subjects suffering from major depressive disorder.
详细描述
Up to 30 patients of any gender aged from 18 to 70 years old will be recruited for inclusion once candidacy has been established by screening criteria.
Once recruited, patients will be randomly assigned to the TMS treatment group or the iTBS treatment group. Patients will be blinded to their group assignment, but will be informed of their assignment upon the final outcome measure collection timepoint (e.g., 1 month post-treatment). Patients who failed to respond by 1-month post iTBS or TMS treatment will be allowed to cross-over into the other treatment group and will be re-enrolled into the study.
For patients assigned to the TMS treatment group, the treatment protocol will consist of 20 sessions of TMS treatment. Each TMS session will deliver 5,000 pulses (120-140% MT, continuous temperature of 24C) over an 61 minute, 51 second time period. Patients will have one TMS session per day, five days a week, until their treatment is completed (approximately four weeks). Upon completion, the patient's depressive symptomatology and severity will be assessed using the same outcome measures used at baseline.
For patients assigned to the iTBS treatment group, the treatment protocol will consist of 20 sessions of iTBS treatment. Each iTBS session will deliver 1,800 pulses (120-140% MT, continuous temperature of 24C) over an 9-minute-40-second period. Patients will have up to four iTBS sessions per day, five days a week, until their treatment is completed (approximately 1 week). Upon completion, the patient's depressive symptomatology and severity will be assessed using the same outcome measures used at baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major Depressive Disorder
- •Score greater than 13 on the Beck Depression Inventory
- •Failure to remit with 3 antidepressants
- •At least 18 years of age
- •Must be willing to comply with the study protocol
- •English Proficiency
排除标准
- •Hepatic impairment
- •Significant cytopenia
- •Cardiovascular, cerebrovascular, and peripheral vascular arterial thrombosis
- •Advanced terminal illness
- •Any active cancer or chemotherapy
- •Bone marrow disease
- •Neurodegenerative diseases
- •Myeloproliferative disorders
- •Sickle cell disease
- •Subjects with scalp rash or open wounds on the scalp
- •Women who are pregnant, may become pregnant, or are breastfeeding
- •Subjects unable to give informed consent or in vulnerable categories, such as prisoners
- •Subjects who would not be able to lay down without excessive movement
- •Recent surgery or dental work within 3 months of the scheduled procedure
- •Not English Proficient
- •Advanced stages of any terminal illness or any active cancer that requires chemotherapy
- •History of epilepsy or seizure, or history of such in first degree relative
- •An increased risk of seizure for any reason
- •Stents in the neck or brain
- •Aneurysm clips or coils
- •Metal devices/objects in or near the head
- •Metallic implants near the ears and eyes
- •Facial tattoos with metallic or magnetic-sensitive ink
- •Comorbid psychiatric conditions
结局指标
主要结局
Beck Depression Inventory (BDI-II)
时间窗: 1 month
The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
Hamilton Depression Rating Scale (HAM-D)
时间窗: 1 month
The HAM-D is a 17-item, interview style questionnaire. A trained staff member administers this form to a patient and scores the patients' responses on a scale of "0" (symptom absent) to "4" (most severe option per symptom). A higher total score indicates a more severe level of depression. The maximum possible score is 50 points. A change in score of at least 30% is considered clinically meaningful.
Patient Depression Questionnaire (PDQ-9)
时间窗: 1 month
The PDQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.
Global Rating of Change (GRC)
时间窗: 1 month
The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.
次要结局
- Beck Depression Inventory (BDI-II)(2 months)
- Patient Depression Questionnaire (PDQ-9)(2 months)
- Hamilton Depression Rating Scale (HAM-D)(2 months)
- Global Rating of Change (GRC)(2 months)