Efficacy and safety of repetitive transcranial magnetic stimulation in the treatment of medication-resistant bipolar depression: a randomized, double-blind, sham-controlled trial - EASyS-BD

oda Takamasa0 个研究点目标入组 96 人开始时间: 2019年3月1日最近更新: 2023年10月17日

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•Each potential subject must satisfy all of the following criteria to be enrolled in the study.
•1. Subjects must be meet Diagnostic and Statistical Manual of Mental Disorders-5 Edition (DSM-5) diagnostic criteria for Bipolar Disorders (included type I and II), and depressive episode without rapid cycler.
•2. Subjects must be a man or woman, 20 to 75 years of age, inclusive.
•3. Have a Hamilton Rating Scale for Depression total score not less than 18.
•4. Have a current depressive episode under 3 years.
•5. Subject must have had an inadequate response in the current episode of depressive episode to at least one pharmacotherapy during 8 weeks as below.
•Lithium, appropriate blood concentration greater than 0.8mEq/L
•Quetiapine, 300mg/day
•Olanzapine, 5-20mg/day
•Lurasidone, 20-60mg/day
•Lamotrigine, 200mg/day

•Any potential subject who meets the following criteria will be excluded from participating in the study.
•1. Subject has a current or prior diagnosis of a psychotic disorder, Obsessive-compulsive disorder, Post Traumatic Stress Disorder, or Eating disorder.
•2. Subject has a treatment history with Electro-convulsive therapy, Repetitive transcranial magnetic stimulation, Deep Brain Stimulation, Transcranial Direct Current Stimulation, or Vagus nerve stimulation.
•3. Subject is a woman who is pregnant.
•4. Patients with a medical history of convulsive disorders (e.g., epilepsy) and patients with the close relatives (first-degree relatives) with the same history.
•5. Subject has a current or prior diagnosis of a Neurological disorder or Organic mental disorder.
•6. Has a history of substance abuse (drug or alchol) or dependence.
•7. Patients with magnetic bodies such as pacemakers, cochlear implants, and intracranial clips (screening is performed by supplementary document).
•8. Has a serious metabolic or endocrine disturbances.
•9. Subject has a serious suicidal ideation (HAM-D suicidal ideation sub-scale score not less than 3)
•10. Patients receiving medication (e.g. Neuroleptics, Tricyclic antidepressants) that decreases seizures threshold.
•11. Subject considered by the principal investigator and sub-investigator(s) to be inappropriate for the safe conduct of the study.

发起方

oda Takamasa