JPRN-jRCTs032180138
Recruiting
Phase 2
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 sites96 target enrollmentMarch 1, 2019
ConditionsBipolar disorder
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Bipolar disorder
- Sponsor
- oda Takamasa
- Enrollment
- 96
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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\)
Outcomes
Primary Outcomes
Not specified
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