An Open-Label Study to Evaluate the Efficacy and Safety of the Neuronetics NeuroStar TMS Therapy System in Patients With Major Depressive Disorder (MDD) With Postpartum Onset.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Neuronetics
- 入组人数
- 25
- 试验地点
- 16
- 主要终点
- Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS therapy in women who have postpartum depression.
详细描述
Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset.
Determine the safety of NeuroStar TMS Therapy by assessment of any medically significant, device-related adverse events during acute treatment.
Determine the Safety of NeuroStar TMS Therapy by assessment of maternal and infant interactions on standardized bonding questionnaires.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female outpatients, 18 to 50 years of age.
- •Diagnosis of DSM-IV defined Major Depressive Disorder, single or recurrent episode, with current episode duration of at least 2 weeks.
- •Onset and duration of current illness within 6 months of live childbirth.
- •HAMD17 total score of greater than or equal to 18 and a score on the Edinburgh Postnatal Depression scale (EPDS) greater than or equal to
- •Patient cannot be on an antidepressant or other psychotropic medications during the study.
- •Capable and willing to provide informed consent.
- •Signed HIPAA authorization.
- •Able to adhere to the treatment schedule.
排除标准
- •Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated): Depression secondary to a general medical condition, or substance-induced Seasonal pattern of depression as defined by DSM-IV;History of substance abuse or dependence within the past year(except nicotine and caffeine);Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes;Bipolar disorder;Eating disorder (current or within the past year);Obsessive compulsive disorder (lifetime); or Post-traumatic stress disorder (current or within the past year).
- •Individuals with a clinically defined neurological disorder or insult including, but not limited to:Any condition likely to be associated with increased intracranial pressure;Space occupying brain lesion;History of cerebrovascular accident;Transient ischemic attack within two years; Cerebral aneurysm; Dementia;Parkinson's disease;Huntington's chorea;Multiple sclerosis.
- •History of treatment with Vagus Nerve Stimulation.
- •History of failure to respond to an adequate course of ECT treatment.
- •Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- •Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
- •Women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.
结局指标
主要结局
Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment
时间窗: Pre to post treatment (Duration range 4 to 8 weeks)
The EPDS is a ten-item questionnaire used for screening for postpartum depression. Total scores range from 0 to 30. Mothers who score above 10 are likely to suffer a depressive illness, while scores above 13 are likely to represent major depression. Higher score at EOA means worse outcome. Once patient reached remission (EPDS\<9), this was EOA treatment and scores were collected.
次要结局
- Percentage of Patients Who Reached Remission After TMS Treatment(upto 8 weeks plus 3 week taper.)