Depressive Disorder, Major, Transcranial Magnetic Stimulation
Conditions
Keywords
repeated transcranial magnetic stimulation, geriatric depression, anxiety, cognitive impairment, heart rate variability
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.
Interventions
Magstim® Super Rapid² Transcranial Magnetic Stimulation System
Sponsors
National Taiwan University Hospital, Yun-Lin Branch
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Change in 17-item Hamilton Depression Rating Scale (HAM-D 17) | day 1, day 5, day 12, day 19 | HAM-D 17 is a scale rating the severity of depression, covering emotional, cognitive and somatic symptoms of depression. Higher scores indicate higher severity. Response to treatment is defined as ≥ 50% decrease in HAM-D 17; remission is defined as ≤ 7 points in HAM-D 17. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Change in Mini-Mental State Examination (MMSE) | day 1, day 5, day 12, day 19 | MMSE is a wildly-used tool to evaluate several cognitive function domains. |
| Degree of Change in Stroop Test | day 1, day 5, day 12, day 19 | Task 1 (word phase) requests a subject to say a color name string (red, green, blue) printed in black; Task 2 (color phase) requests a subject to say the printed colors (red, green, blue) of letter x string; Task 3 (interference phase) requests a subject to say the printed colors of a string of color names (red, green, blue). |
| Degree of Change in Hamilton Anxiety Rating Scale (HAM-A) | day 1, day 5, day 12, day 19 | HAM-A is a scale rating the severity of anxiety, covering emotional, cognitive and somatic symptoms of anxiety. Higher scores indicate higher severity. |
| Degree of Change in Verbal Fluency Test | day 1, day 5, day 12, day 19 | This test requests a subject to speak as many names of vegetables, fishes or fruit as possible in 45 seconds. |
| Degree of Change in Physiological Parameters | day 1, day 5, day 12, day 19 | ProComp5 Infiniti (SA7525) Biofeedback System would be used. Heart rate variability, skin conductance, body temperature and respiratory rate would be measured. |
| Degree of Change in Trail Making Test | day 1, day 5, day 12, day 19 | Task 1 requests a subject to connect a sequence of 25 consecutive numbers regardless of their colors; Task 2 requires a subject to connect 25 consecutive numbers in alternative colors. |
Countries
Taiwan
Outcome results
None listed