Development of a new form of rTMS treatment for TRD
- Conditions
- Treatment Resistance Depression
- Registration Number
- JPRN-jRCTs032180188
- Lead Sponsor
- oda Yoshihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 180
(1) Outpatients or inpatients of Neuropsychiatry, Keio University Hospital
(2) 18 years old or over when obtaining consent
(3) Patient who is able to give a written consent according to an attending physician
(4) Meeting the diagnostic criteria of Major Depressive disorder based on DSM-5
(5) The current episode is scored 3 or greater in ATHF, or nonresponsive to two different kind of antidepressants in the past
(6) The score 18 or greater MADRS
(7) Mental condition is stable enough for the examination
(1)Patients with organic brain disorder (Moderate or severe intracranial organic lesions or neurodegenerative disease)
(2) History of seizures and/or epilepsy
(3) Diagnosis of substance related disorders in the last 6 months
(4) Serious or unstable physical condition
(5) Received rTMS or ECT treatment in the last 6 months
(6) Having contraindications of TMS or MRI, such as metal-containing objects or a heart pacemaker implanted in the body or claustrophobic
(7) The size of the head, neck, or body not suitable for MRI devices
(8) Other cases considered unsuitable for the study by the investigator or collaborating physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute phase: Difference between Montgomery Asberg Depression Rating Scale(MADRS) from baseline to endpoint<br>Maintenance phase: Difference between Montgomery Asberg Depression Rating Scale(MADRS) from baseline to endpoint
- Secondary Outcome Measures
Name Time Method