Transcranial Magnetic Stimulation in Pregnant Women with Depressive Disorder

经颅磁刺激治疗抑郁症孕妇

基本信息

批准号：
8399740
负责人：
DEBORAH KIM
金额：
$ 17.67万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-03-16 至 2015-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8399740
关键词：
Address Adult Affect Age Allopregnanolone Antidepressive Agents Award Birth Birth Weight Brain-Derived Neurotrophic Factor Child Clinical Research Clinical Treatment Congenital Abnormality Controlled Clinical Trials Corticotropin-Releasing Hormone Data Depressive disorder Development Devices Discipline of obstetrics Double-Blind Method Endocrine Endogenous depression Estradiol Evaluation Event Extramural Activities FDA approved Funding Gestational Age Goals Gynecology Health Individual K-Series Research Career Programs Laboratories Luteal Phase Major Depressive Disorder Measures Mental Depression Mental Health Mental disorders Mentors Mentorship Metabolic Monitor Mothers Motor Neuroendocrinology Neurosecretory Systems Organogenesis Output Oxytocin Patients Perinatal Peripheral Pharmaceutical Preparations Pilot Projects Placebo Control Population Prefrontal Cortex Pregnancy Pregnancy Outcome Pregnant Women Prevalence Progesterone Psychiatry Psychotherapy Randomized Research Research Personnel Research Project Grants Rest Safety Sampling Scientist Serum Severities Supervision Testing Training Transcranial magnetic stimulation Translational Research United States Woman Work alternative treatment career clinical remission comparison group design effective therapy experience fetal impression maternal serum meetings named group offspring patient oriented patient oriented research pregnant programs public health relevance repetitive transcranial magnetic stimulation research study skills treatment response

项目摘要

DESCRIPTION (provided by applicant): The Candidate proposes this Mentored Patient-Oriented Research Career Award application to provide her with expert training and mentorship to support her development as an independent clinician scientist in the field of perinatal mental health. The long-term career goals of the Candidate are 1) To establish a program of research focusing on the treatment and predictors of treatment response for major psychiatric disorders in pregnant women; 2) To develop the translational aspects of her clinical research program by fully incorporating a sophisticated understanding of the neuroendocrinology of pregnancy; 3) To develop her skills as an independent investigator, educator and mentor focusing on patient-oriented research at the interface between psychiatry and obstetrics and gynecology. In order to meet these goals, the application provides a detailed description of 5 training modules including 1) Research projects, 2) Laboratory training, 3) Didactic course work including completion of a Masters in Translational Research, 4) Individual tutorials, and 5) Extramural supervision. The development of researchers focused on the treatment of depression during pregnancy has important ramifications for mother and her offspring. Depression during pregnancy affects approximately 13% of pregnant women making it a national health issue of vital importance. There is mounting evidence that antidepressants may adversely affect pregnancy outcome and fetal health. Psychotherapy is a first-line treatment for this special population but other options must be studied as no treatment will work in all patients. Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved device for the non-pharmacologic treatment of depression in adults. It is critical that rTMS, as a non-pharmacologic treatment, be evaluated for the treatment of major depressive disorder (MDD) during pregnancy. Our pilot data suggests this is a feasible and safe treatment for 2nd and 3rd trimester pregnant women with depression. Our pilot data also suggests that the device parameters may be affected by the pregnant state which if not addressed could affect efficacy. We propose a double-blind, placebo-controlled clinical trial using 1 Hz active versus sham rTMS of the right dorsolateral prefrontal cortex (DLPFC) of 66 pregnant women with moderate to severe major depressive disorder (MDD). We expect a significant decrease in depression scores after 20 sessions in the active group compared to the sham group. In addition, we will evaluate the device power output necessary to obtain the resting motor threshold in pregnant subjects compared to 16 age-matched, non-pregnant, healthy women in the luteal phase of the menstrual cycle. Finally, to better understand the mechanism by which rTMS may be effective for the treatment of depression during pregnancy, we will measure maternal serum brain derived neurotrophic factor (BDNF) and correlate it with levels of estradiol, progesterone, allopregnanolone, oxytocin and corticotrophin-releasing hormone (CRH) levels pre and post-rTMS. This award will solidly prepare the Candidate to pursue further research funding and the development of non-pharmacological, somatic treatments for pregnant women suffering from mental illness.

描述（由申请人提供）：候选人提出了这一受过指导的注重患者的研究职业奖申请，以为她提供专家培训和指导，以支持她作为围产期心理健康领域的独立临床医生的发展。候选人的长期职业目标是1）建立一项研究计划，重点是孕妇主要精神疾病的治疗方法和治疗反应的预测因素； 2）通过完全融合了对妊娠神经内分泌学的复杂理解，以发展其临床研究计划的翻译方面； 3）为了发展她作为独立研究者，教育者和导师的技能，专注于精神病学与妇产科和妇科之间的界面上的以患者为导向的研究。为了实现这些目标，该应用程序提供了5个培训模块的详细说明，包括1）研究项目，2）实验室培训，3）教学课程工作，包括完成转化研究的硕士学位，4）单个教程和5）5）校外监督。专注于怀孕期间抑郁症治疗的研究人员的发展对母亲和她的后代产生了重要影响。怀孕期间的抑郁会影响约13％的孕妇，使其成为重要重要性的国家健康问题。有越来越多的证据表明抗抑郁药可能会对妊娠结局和胎儿健康产生不利影响。心理治疗是针对该特殊人群的一线治疗方法，但必须研究其他选择，因为所有患者都没有治疗作用。重复的经颅磁刺激（RTMS）是FDA批准的装置，用于成人抑郁症的非药物治疗。在怀孕期间，评估RTMS作为非药物治疗的RTM，以治疗重度抑郁症（MDD）。我们的飞行员数据表明，这是对抑郁症的第二和第三三个月孕妇的可行且安全的治疗。我们的试点数据还表明，设备参数可能会受到怀孕状态的影响，如果没有解决，可能会影响疗效。我们提出了一项双盲，安慰剂对照的临床试验，使用1 Hz活性与右背外侧前额叶皮层（DLPFC）的SHAM RTM，对66名中度至重度重度抑郁症（MDD）的孕妇进行。与假手术组相比，我们预计在活动组20个疗程后的抑郁评分显着下降。此外，我们将评估获得怀孕受试者的静息电动机阈值所需的设备功率输出，而在月经周期的黄体期中，16岁年龄匹配，非怀孕，健康的女性。最后，为了更好地了解RTM在怀孕期间可能有效治疗抑郁症的机制，我们将测量孕妇血清脑衍生的神经营养因子（BDNF），并将其与雌二醇，孕酮，异丙醇，羟基苯酚，氧毒素和corticotrophin-释放的群（Crhorson-creporeone（Crhornosone preptrs and post-preptrs）的水平相关联。该奖项将为候选人做好准备，以寻求进一步的研究资金以及针对患有精神疾病的孕妇的非药理，躯体治疗的发展。