Accelerated Bilateral rTMS on Geriatric Depression

Depressive Disorder, Major Clinical Trial

Official title:

Therapeutic Effect of Accelerated Bilateral Repeated Transcranial Magnetic Stimulation on Geriatric Depression: a Prospective Double-blind, Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04486222
• Other study ID #: 201910101RIND
• Status: Terminated
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: December 21, 2022

Study information

• Verified date: May 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Transcranial Magnetic Stimulation

Intervention

Device:
• Repeated Transcranial Magnetic Stimulation
Magstim® Super Rapid² Transcranial Magnetic Stimulation System

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, National Taiwan University Hospital, Yun-Lin Branch	Douliu

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan University Hospital, Yun-Lin Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Degree of Change in Hamilton Anxiety Rating Scale (HAM-A)	HAM-A is a scale rating the severity of anxiety, covering emotional, cognitive and somatic symptoms of anxiety. Higher scores indicate higher severity.	day 1, day 5, day 12, day 19
Secondary	Degree of Change in Mini-Mental State Examination (MMSE)	MMSE is a wildly-used tool to evaluate several cognitive function domains.	day 1, day 5, day 12, day 19
Secondary	Degree of Change in Stroop Test	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).	day 1, day 5, day 12, day 19
Secondary	Degree of Change in Trail Making Test	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.	day 1, day 5, day 12, day 19
Secondary	Degree of Change in Verbal Fluency Test	This test requests a subject to speak as many names of vegetables, fishes or fruit as possible in 45 seconds.	day 1, day 5, day 12, day 19
Secondary	Degree of Change in Physiological Parameters	ProComp5 Infiniti (SA7525) Biofeedback System would be used. Heart rate variability, skin conductance, body temperature and respiratory rate would be measured.	day 1, day 5, day 12, day 19