Repetitive transcranial magnetic stimulation for bipolar depression.
- Conditions
- Bipolar disorder
- Registration Number
- JPRN-jRCTs032180138
- Lead Sponsor
- oda Takamasa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 96
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method