NCT00657735Unknown不适用
A Prospective Double Blind Randomized Controlled Trial To Explore The Tolerability, Safety And Efficacy Of The H1-Coil Deep Transcranial Magnetic Stimulation (TMS) In Subjects With Bipolar Depression
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change in the Hamilton depression rating scale score
研究概览
简要总结
The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression , currently treated with mood stabilizer and previously unsuccessfully treated with antidepressant medications
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Diagnosed by two senior psychiatrists as suffering from bipolar depression (BP1, BP2) episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID), with additional requirement of duration for the current episode ≥ 4 weeks and CGI ≥
- •Rating on HAM-D (17 items) >20 and item 1 ≥2 at the screening visit.
- •Age: 18-65 years.
- •Gave informed consent for participation in the study.
- •Negative answers on safety screening questionnaire for transcranial magnetic stimulation
- •Taking mood stabilizing medication (e.g., lithium) on an acceptable range of dosage according to recent blood examination or antipsychotic medication as mood stabilizers prescribed by their treating physician
- •According to the treating physician the patient is compliant in taking the mood-stabilizing medication.
- •Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 2 antidepressant drug trials of adequate dose and duration in the current episode or previous episodes defined as a minimum level of 3 on the ATHF per antidepressant drug-trial.
- •Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to 3 or more anti-depressant medications in the current or a previous episodes.
- •If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.
- •Able to tolerate psychotropic medication washout and no psychotropics during the H-coil deep brain rTMS other than benzodiazepine at equivalent dose of up to 3 mg lorazepam every day.
- •Right hand dominance.
排除标准
- •Diagnosis as suffering from other diagnosis on axis 1 (like: schizophrenia, geriatric depression).
- •Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.
- •Substantial suicidal risk as judged by the treating psychiatrist.
- •Attempted suicide in the past year.
- •Patients with a bipolar cycle of less than 30 days.
- •History of epilepsy or seizure in first degree relatives.
- •History of head injury.
- •History of any metal in the head (outside the mouth).
- •Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- •History of frequent or severe headaches.
- •History of migraine.
- •History of hearing loss.
- •Known history of cochlear implants
- •History of substance abuse within the past 6 months (except nicotine and caffeine) or alcoholism
- •Pregnancy or not using a reliable method of birth control.
- •Unstable Systemic and metabolic disorders.
- •Unstable neurological or medical disease
- •Inadequate communication with the patient.
- •Under custodial care.
- •Participation in current clinical study or clinical study within 30 days prior to this study.
结局指标
主要结局
change in the Hamilton depression rating scale score
时间窗: 7 weeks
次要结局
- Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.(7 weeks)
研究者
研究点 (1)
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