Bipolar disorder Bipolar disorder
Conditions
Interventions
Repetitive transcranial magnetic stimulation (rTMS) is administered using MagPro R30 (MagVenture, Denmark). The stimulation condition is a stimulation frequency of 1 Hz, a stimulation intensity of 120
Repetitive transcranial magnetic stimulation
Sponsors
Noda Takamasa
Eligibility
Sex/Gender
All
Inclusion 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 Lamotrigine, 200mg/day
Exclusion criteria
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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response/ remission maintenance rate, relapse/recurrence rate, and the time to relapse or recurrence during the observation period. The change in scores of Montgomery and Asberg Depression Rating Scale (MADRS), Hamilton Depression Rating Scale 17-items (HAMD17), Patient Health Questionnaire depression module (PHQ-9), Clinical Global Impressions Scale (CGI), Young Mania Rating Scale (YMRS), EuroQol 5 Dimensions (EQ-5D), Brief Assessment of Cognition in Schizophrenia (BACS), and THINC-integrated tool (THINC-it), during the acute treatment and observation periods. Safety evaluation parameters Adverse events, particularly headache, stimulation site pain, stimulation site discomfort, presence or absence of muscle contraction. The presence of suicidal ideation and Manic/hypomanic switches. | — |
Contacts
Public ContactTakamasa Noda
National Center of Neurology and Psychiatry (NCNP)
Outcome results
None listed