Accelerated Bilateral rTMS on Geriatric Depression

NCT04486222 | Terminated

• 1 other identifier: 201910101RIND
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcranial Magnetic Stimulation; Depressive Disorder, Major

Keywords

repeated transcranial magnetic stimulation; geriatric depression; anxiety; cognitive impairment; heart rate variability

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1, day 5, day 12, day 19

Secondary Outcomes (6)

• Degree of Change in Hamilton Anxiety Rating Scale (HAM-A)

  day 1, day 5, day 12, day 19

• Degree of Change in Mini-Mental State Examination (MMSE)

  day 1, day 5, day 12, day 19

• Degree of Change in Stroop Test

  day 1, day 5, day 12, day 19

• Degree of Change in Trail Making Test

  day 1, day 5, day 12, day 19

• Degree of Change in Verbal Fluency Test

  day 1, day 5, day 12, day 19

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Device: Repeated Transcranial Magnetic Stimulation

Standard Treatment Group

ACTIVE COMPARATOR

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.

Device: Repeated Transcranial Magnetic Stimulation

Interventions

Repeated Transcranial Magnetic Stimulation DEVICE

Magstim® Super Rapid² Transcranial Magnetic Stimulation System

Experimental Group; Standard Treatment Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital, Yun-Lin Branch: collaborator

Study Sites (1)

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

Douliu, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 24, 2020
• Study Start: November 23, 2020
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: January 4, 2023

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)