NCT01583023Unknown4 期
Assessing the Efficacy of Left Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunctive Treatment to Mood Stabilizers for the Treatment of Bipolar Depression
McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks
研究概览
简要总结
The purpose of this study is to evaluate whether repetitive transcranial magnetic stimulation (rTMS) treatment is an effective adjunct treatment to mood stabilizers and Bupropion.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BD Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) in depressed phase.
- •Rating on the Montgomery-Asberg Depression Rating Scale (MADRS) score >
- •Rating on the Beck Depression Inventory (BDI-II) >
- •Rating on the Young Mania Rating Scale (YMRS) <
- •Non-treated new depressive episode, at least 2 weeks in duration. If recently started on an antidepressant other than Wellbutrin, subject must spend at least 4 weeks at a therapeutic dose before entering the study.
- •Lithium and epival (Sodium Valproate) in monotherapy or in combination. Novel antipsychotics can be combined with mood stabilizers for at least 4 weeks at a steady dosage prior to the study.
排除标准
- •History of any DSM-IV Axis I diagnosis other than BD Type I or II Presence of any psychotic symptoms, characterized by a score of 3 or more on item 10 of the MADRS, a score of 6 on item 9 of the MADRS, or a score of 6 or more on item 8 of the YMRS Comorbid active dependence or substance abuse (except nicotine) Prior electroconvulsive therapy failure Pacemaker, automatic implantable defibrillator or implantable pump Aneurysm Clip Heart/Vascular Clip Prosthetic Valve Metal Prosthesis Pregnancy (must do a blood β-HCG test to exclude) Metal or metal fragments in the head Personal or Family history of seizure disorder Increased Intracranial pressure History of stroke, meningitis/encephalitis, moderate to severe traumatic brain injury, neurosurgical procedure Pharmacotherapy using any substances not mentioned in the inclusion criteria, except benzodiazepines at an equivalent dose of less than or equal to 1mg/day of lorazepam.
- •Failure of previous Wellbutrin treatment. Mood disorder secondary to a medical condition. Subject currently enrolled in any detoxification program
研究组 & 干预措施
Wellbutrin + Lithium a/o Epival + Sham rTMS
Experimental
干预措施: Bupropion (Drug)
Wellbutrin + Lithium a/o Epival + Sham rTMS
Experimental
干预措施: Sham repetitive transcranial magnetic stimulation (Device)
Placebo + Lithium a/o Epival + Active rTMS
Experimental
干预措施: Active Repetitive Transcranial Magnetic Stimulation (Device)
Placebo + Lithium a/o Epival + Active rTMS
Experimental
干预措施: Placebo (Other)
Wellbutrin + Lithium a/o Epival + Active rTMS
Experimental
干预措施: Bupropion (Drug)
Wellbutrin + Lithium a/o Epival + Active rTMS
Experimental
干预措施: Active Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks
时间窗: 8 weeks
次要结局
- Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks(8 weeks)
- Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks(8 weeks)
- Alcohol use disorder identification test (AUDIT Assessment)(At intake)
- Drug abuse screen test (DAST Assessment)(At intake)
- Clinical Global Impression (CGI) & Analog scale(8 weeks)
研究者
Pablo Cervantes
Director of the Mood Disorders Clinic
McGill University Health Centre/Research Institute of the McGill University Health Centre
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Brain Stimulation for Traumatic Brain InjuryTraumatic Brain InjuryDiffuse Axonal InjuryNCT02167971University of Sao Paulo30
已完成
不适用
Repeated Transcranial Magnetic Stimulation Relieves Maternal Care ImpairmentMaternal Care PatternsRepetitive Transcranial Magnetic Stimulation (rTMS)Functional Magnetic Resonance ImagingNCT06743724The First Affiliated Hospital of Soochow University45
已完成
不适用
Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of DepressionDepressionNCT01516931Xijing Hospital391
Unknown
不适用
Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of SchizoaffectiveSchizoaffective DisorderNCT02221635Xijing Hospital540
终止
不适用
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of EpilepsyEpilepsia Partialis ContinuaStatus EpilepticusNCT02560597University Hospital, Ghent4