A 12-Month Prospective Randomized Dual-Arm Pilot Study of Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Neuronetics
- 入组人数
- 67
- 试验地点
- 12
- 主要终点
- Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of scheduled maintenance Transcranial Magnetic Stimulation (TMS) treatment compared to on-demand TMS treatment for symptomatic worsening in patients who have shown a clinical response to acute TMS treatment.
详细描述
This is a 12-month maintenance treatment study for patients who have responded to a 6 week course of acute TMS treatment for major depressive disorder (MDD). The study will seek to assess the change in depressive symptomatology across the duration of maintenance treatment using observer and self-administered efficacy measures. Describe the efficacy of TMS re-introduction in patients not receiving maintenance pharmacotherapy who show a recurrence of depressive symptoms. Assess the safety and durability of acute TMS therapy followed by maintenance TMS treatment for up to 12 months.
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
- None
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
- •Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single episode or recurrent course of illness, with the additional stipulation of a duration for this episode of ≥ 4 weeks and CGI-S ≥
- •Duration of current episode of depression ≤ 3 years (the definition of an episode is demarcated by a period of ≥ 2 months when the patient did not meet full criteria for the DSM-IV definition of Major Depressive Episode.
- •Capable and willing to provide informed consent.
- •Signed HIPAA authorization.
- •Able to adhere with the treatment schedule, and withdrawal of ongoing pharmacotherapy.
- •If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.
排除标准
- •Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
- •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).
- •An Axis II Personality Disorder, which in the judgment of the Investigator may hinder the patient in completing the procedures required by the study protocol.
- •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.
- •Increased risk of seizure for any reason, including but not limited to prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for ≥ 5 minutes.
- •History of treatment with Vagus Nerve Stimulation.
- •Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
结局指标
主要结局
Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.
时间窗: 12 month evaluation
Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.
次要结局
- Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms.(12 Month evaluation)