Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2020-11-23
2022-12-21
Brief Summary
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Detailed Description
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Cognitive impairment and decreased parasympathetic tone are common in patients with major depression. The investigators hypothesize cognitive function and physiological indicators improve after accelerated bilateral rTMS.
In this single-center, prospective double-blind, randomized, active-controlled trial, the investigators aim to recruit 100 patients older than 60 years, without neurocognitive disorders, and refractory to one or more antidepressants. The experimental group would receive an rTMS course with high-frequency stimulation at left DLPFC followed by low-frequency inhibition at right DLPFC, two sessions daily, five days a week, and two weeks in total. The standard treatment group would receive an rTMS course with high-frequency stimulation at left DLPFC as standard treatment parameters. Mood, cognition and physiological markers would be monitored every week. The primary outcome is response and remission rate of major depression measured by Hamilton Rating Scale for Depression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental Group
The experimental group would receive an rTMS course with high-frequency stimulation (10Hz) at left DLPFC (120% motor threshold, 40 trains, 1600 pulses) followed by low-frequency (1Hz) inhibition at right DLPFC (120% motor threshold, 10 trains, 1200 pulses), two sessions daily with a 1.5-hour inter-session interval (L't active-R't active-1.5 hr-L't active-R't active), five days a week, and two weeks in total.
Repeated Transcranial Magnetic Stimulation
Magstim® Super Rapid² Transcranial Magnetic Stimulation System
Standard Treatment Group
The standard treatment group would receive an rTMS course with high-frequency stimulation (10Hz) at left DLPFC (120% motor threshold, 40 trains, 1600 pulses) followed by sham inhibition at right DLPFC (1Hz, 10 trains, 1200 pulses); after a 1.5-hour inter-session interval, a sham session would be administered at left and right DLPFC (L't active-R't sham-1.5 hr-L't sham-R't sham. The course would be applied five days a week, and two weeks in total.
Repeated Transcranial Magnetic Stimulation
Magstim® Super Rapid² Transcranial Magnetic Stimulation System
Interventions
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Repeated Transcranial Magnetic Stimulation
Magstim® Super Rapid² Transcranial Magnetic Stimulation System
Eligibility Criteria
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Inclusion Criteria
* literate and received basic education for at least 2 years
* diagnosis of major depressive disorder, without psychotic features, according to DSM-5
* have a score of 20 or greater on the 17-item Hamilton Depression Rating Scale
* failed to achieve clinical response by at least 1 antidepressant trial of sufficient dosage for at least 4 weeks
* psychoactive agents were in stable doses before randomization
Exclusion Criteria
* diagnosis of schizophrenia or bipolar disorder according to DSM-5
* have DSM-5-confirmed substance use disorder (excluding tobacco) in the last 3 months
* have delirium, major neurocognitive disorder or MMSE \< 24
* current use of bupropion \>300 mg/day, tricyclic antidepressant, clozapine, chlorpromazine, foscarnet, ganciclovir, ritonavir, theophylline or anti-epileptic agents excluding benzodiazepines
* history of severe head trauma, epilepsy, multiple sclerosis, stroke, brain tumors, intracranial aneurysm, active intracranial infection, increased intracranial pressure, metallic implants in the brain, major brain surgery or major neurological diseases
* with a cardiac pacemaker or defibrillator
* received rTMS treatment before
60 Years
85 Years
ALL
No
Sponsors
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National Taiwan University Hospital, Yun-Lin Branch
OTHER
National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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Department of Psychiatry, National Taiwan University Hospital, Yun-Lin Branch
Douliu, , Taiwan
Countries
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Other Identifiers
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201910101RIND
Identifier Type: -
Identifier Source: org_study_id
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