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Antidepressant efficacy of prefrontal theta-burst stimulation on refractory depression: a randomized sham-controlled study combining neuroimaging

Phase 4
Recruiting
Conditions
A treatment option for Medication-resistant depression
Registration Number
JPRN-UMIN000044951
Lead Sponsor
Grant of Taipei Veterans General Hospital, Taiwan
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
210
Inclusion Criteria

Not provided

Exclusion Criteria

Patients were excluded if (1) they had a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria) (2) or probable dementia diagnosis based on a Mini Mental Status Exam (MMSE) score of <26 and clinical evidence of dementia.(3) People with a lifetime medical history of major systemic illness and neurological disorder records (e.g., stroke, seizure, (4) traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers, and (5) pregnant women were also excluded. (6) regarding to potential safety issues during the monotherapy period of brain stimulation, patients with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17) (7)receiving bupropion >300 mg/day due to dose-dependent increased risk of seizures, or receiving lorazepam >2 mg/day or any anticonvulsant due to reduced cortical excitability which may interfere with rTMS efficacy were excluded

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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