Clinical trial NCT04486222: Accelerated Bilateral rTMS on Geriatric Depression
Official title: Therapeutic Effect of Accelerated Bilateral Repeated Transcranial Magnetic Stimulation on Geriatric Depression: a Prospective Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Depressive Disorder, Major
Keywords: repeated transcranial magnetic stimulation
geriatric depression
anxiety
cognitive impairment
heart rate variability
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
First posted: 2020-07-24
Enrollment: 2
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of accelerated bilateral repetitive transcranial magnetic stimulation (rTMS) on major depression, anxiety, cognitive function and physiological parameters in elderly depressive patients.

Detailed description: Repeated transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation treatment, showing good therapeutic effect to medicine treatment-refractory patients. Recent studies suggested bilateral DLPFC might be effective to geriatric depression. Accelerated treatment course was reported to have similar therapeutic effect and safety profile with traditional course. The investigators hypothesize accelerated bilateral rTMS is effective to geriatric depression and comorbid anxiety.

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.

Eligibility criteria: Inclusion Criteria:

* age between 60-85 years
* 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:

* active suicide plans or attempts; or suicide attempts in the last 12 months
* 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

Primary outcomes:
measure: Degree of Change in 17-item Hamilton Depression Rating Scale (HAM-D 17)
timeFrame: day 1, day 5, day 12, day 19
Secondary outcomes:
measure: Degree of Change in Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: day 1, day 5, day 12, day 19
measure: Degree of Change in Mini-Mental State Examination (MMSE)
timeFrame: day 1, day 5, day 12, day 19
measure: Degree of Change in Stroop Test
timeFrame: day 1, day 5, day 12, day 19
measure: Degree of Change in Trail Making Test
timeFrame: day 1, day 5, day 12, day 19
measure: Degree of Change in Verbal Fluency Test
timeFrame: day 1, day 5, day 12, day 19
measure: Degree of Change in Physiological Parameters
timeFrame: day 1, day 5, day 12, day 19
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: Department of Psychiatry, National Taiwan University Hospital, Yun-Lin Branch
Study officials:
References: