Accelerated Bilateral rTMS on Geriatric Depression

National Taiwan University Hospital2 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Transcranial Magnetic Stimulation Depressive Disorder, Major

Interventions

Repeated Transcranial Magnetic StimulationDEVICE

Magstim® Super Rapid² Transcranial Magnetic Stimulation System

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychiatry, National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

Outcomes

Primary Outcomes

Degree of Change in 17-item Hamilton Depression Rating Scale (HAM-D 17)

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.