Transcranial Magnetic Stimulation (TMS) in Pregnant Women With Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment
研究概览
简要总结
The purpose of this study is to determine if repetitive transcranial magnetic stimulation (TMS) will alleviate symptoms of major depressive disorder (MDD) in pregnant women.
TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more effectively with one another. Effective neuron communication is thought to lead to the lessening of depressive symptoms. In this study subjects require daily TMS treatment for approximately four weeks.
详细描述
We hypothesize that there will be a decline in the Hamilton Rating Scale for Depression (HDRS-17) scores from the beginning to end of treatment. We expect that this decrease will be significantly greater in subjects receiving active transcranial magnetic stimulation (TMS) compared to those receiving placebo TMS. Treatment response will be defined as greater than 50% reduction in HDRS-17 score.
We also hypothesize that levels of Brain Derived Neurotrophic Factor (BDNF), a protein thought to regulate mood and cognitive functioning, will increase in subjects who respond to TMS treatment. We expect BDNF levels to increase by greater than or equal to 20% in those who respond to TMS. As previously stated, TMS response will be defined as a significant decrease (50% or greater) in the HDRS-17 from baseline to end of treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects are capable of giving written informed consent and complying with all study procedures;
- •Female age 18-39 years old at date of enrollment;
- •Pregnant, weeks 14-34;
- •Current Depressive Symptoms;
- •No change in antidepressant medication at least two weeks prior to study entry if using an antidepressant.
排除标准
- •Any alcohol or drug abuse/dependence over the 6 months prior to study entry;
- •History of a seizure disorder in subject or first degree relative;
- •Anti-psychotic, lithium, or anti-convulsant medications within 2 weeks of study enrollment;
- •History of known brain lesions, or severe head trauma;
- •Subjects with any metallic object implanted in the skull;
- •Subjects with significant cardiac disease;
- •Neurological or psychiatric disorders;
- •Serious medical illnesses that may compromise patient safety or study conduct;
- •Currently taking a drug with known potential for fetal toxicity;
- •Previous pregnancy with an adverse fetal outcome;
- •Current obstetrical complications
- •Actively suicidal;
- •History of depression unresponsive to treatment with electroconvulsive therapy (ECT).
结局指标
主要结局
Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment
时间窗: Change score from baseline to test day 20 (after 20 days of intervention)
We measured changes in Hamilton Rating Scale for Depression (HDRS-17) scores from baseline to post-treatment. The HDRS-17 was administered on test days 1, 10, \& 20. Scoring is based on the 17-item scale and scores of 0-7 is generally accepted to be within the normal range, indicating minimal to no depression; scores of 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
次要结局
- Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)(Change in concentration from test day 1 to test day 20)