JPRN-jRCTs032180188
Completed
Phase 2
Development of a new transcranial magnetic stimulation therapy for treatment-resistant depression and identification of its predictor of response - TRD-rTMS longitudinal Study
oda Yoshihiro0 sites180 target enrollmentMarch 6, 2019
ConditionsTreatment Resistance Depression
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Treatment Resistance Depression
- Sponsor
- oda Yoshihiro
- Enrollment
- 180
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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
Exclusion Criteria
- •(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
Outcomes
Primary Outcomes
Not specified
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