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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)

Repetitive transcranial magnetic stimulation for bipolar depression. (EASyS-BD)

Noda Takamasa

National Center of Neurology and Psychiatry (NCNP)

4-1-1 Ogawa-Higashi, Kodaira, Tokyo

t-noda@ncnp.go.jp

Noda Takamasa

National Center of Neurology and Psychiatry (NCNP)

4-1-1 Ogawa-Higashi, Kodaira, Tokyo

+81-42-341-2711

t-noda@ncnp.go.jp

Suspended

May. 01, 2019

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

Both

Bipolar disorder

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% MT, a stimulation time of 1800 seconds, and a stimulation frequency of 1800 times (30 minutes), and low frequency stimulation to the right prefrontal cortex is performed 5 times a week for 4 weeks. Stimulation coil is administered using Cool-B65 A/P (MagVenture, Denmark). Real stimulation and sham stimulation are administered using Cool-B65 A/P (MagVenture, Denmark). rTMS implementer input the Subject code assigned to each patient from the panel of the stimulator body. Real stimulation or sham stimulation is selected by the built-in system from pre-assigned Subject code.

Bipolar disorder

Repetitive transcranial magnetic stimulation

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, 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.

+81-42-341-2712-7828

Oct. 09, 2018

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