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)

未提供0 个研究点目标入组 96 人开始时间: 2019年11月7日最近更新: 2025年4月1日

适应症

试验速览

暂无简介。

•Each potential subject must satisfy all of the following criteria to be enrolled in the study.
•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.
•Subjects must be a man or woman, 20 to 75 years of age, inclusive.
•Have a Hamilton Rating Scale for Depression total score not less than
•Have a current depressive episode under 3 years.
•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.
•Subject has a current or prior diagnosis of a psychotic disorder, Obsessive-compulsive disorder, Post Traumatic Stress Disorder, or Eating disorder.
•Subject has a treatment history with Electro-convulsive therapy, Repetitive transcranial magnetic stimulation, Deep Brain Stimulation, Transcranial Direct Current Stimulation, or Vagus nerve stimulation.
•Subject is a woman who is pregnant.
•Patients with a medical history of convulsive disorders (e.g., epilepsy) and patients with the close relatives (first-degree relatives) with the same history.
•Subject has a current or prior diagnosis of a Neurological disorder or Organic mental disorder.
•Has a history of substance abuse (drug or alchol) or dependence.
•Patients with magnetic bodies such as pacemakers, cochlear implants, and intracranial clips (screening is performed by supplementary document).
•Has a serious metabolic or endocrine disturbances.
•Subject has a serious suicidal ideation (HAM-D suicidal ideation sub-scale score not less than 3)
•Patients receiving medication (e.g. Neuroleptics, Tricyclic antidepressants) that decreases seizures threshold.
•Subject considered by the principal investigator and sub-investigator(s) to be inappropriate for the safe conduct of the study.

MADRS total score

时间窗: 4-week endpoint

The primary efficacy evaluation for each panel will be the MADRS total score as measured by the change from baseline to the 4-week endpoint.

Response/ remission maintenance rate(observation period)
Relapse/recurrence rate(observation period)
Time to relapse or recurrence(observation period)
Montgomery and Asberg Depression Rating Scale (MADRS)(acute treatment and observation periods)
Hamilton Depression Rating Scale 17-items (HAMD17)(acute treatment and observation periods)
Patient Health Questionnaire depression module (PHQ-9)(acute treatment and observation periods)
Clinical Global Impressions Scale (CGI)(acute treatment and observation periods)
Young Mania Rating Scale (YMRS)(acute treatment and observation periods)
EuroQol 5 Dimensions (EQ-5D)(acute treatment and observation periods)
Brief Assessment of Cognition in Schizophrenia (BACS)(acute treatment and observation periods)
THINC-integrated tool (THINC-it)(acute treatment and observation periods)
Adverse events
Suicidal ideation
Manic/hypomanic switches

发起方

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