TBS Over DLPFC in Elderly Refractory Depression

NCT04872465 | Unknown DMC

• 1 other identifier: Kaohsiung VGHKS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aim to examine the effect of Thea-burst stimulation over bilateral dorsolateral prefrontal cortex (DLPFC) among patients with LLD on mood condition and relevant biomarkers.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale, HAM-D

  The Ham-D is the most widely used clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

  Change from baseline after 1, 2 weeks and three months

Secondary Outcomes (2)

• Beck depression inventory, BDI-II

  Change from baseline after 1, 2 weeks and three months

• Beck anxiety inventory, BAI

  Change from baseline after 1, 2 weeks and three months

Study Arms (2)

Experimental

ACTIVE COMPARATOR

We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses).

Device: TBS

Sham Comparator

PLACEBO COMPARATOR

Participants will receive sham (placebo) TBS treatment the same as experimental group

Device: sham

Interventions

TBS DEVICE

We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses).

Experimental

sham DEVICE

Participants will receive sham (placebo) TBS treatment the same as experimental group

Sham Comparator

Eligibility Criteria

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

You may qualify if:

• Aged 60 to 85 years
• Major depression disorder
• Under a stable dose of all psychotropic medication during the stimulation period.

You may not qualify if:

• Having any current psychiatric comorbidity or history of substance dependence.
• Having active suicidal ideation currently.
• Having severe physical illness, recent and/or current unstable medical disorders.
• Having history of cancer or chemotherapy.
• Dementia or MMSE\<24.
• Having TMS contraindicated (seizure disorder, history of seizures, metal in the head, pacemakers, history of craniotomy)

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Department of Psychiatry, Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Che-Sheng Chu, MD

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Che-Sheng Chu, MD

CONTACT

+886-7-3422121; cschu@vghks.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Psychiatry, MD, attending physician

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 4, 2021
• Study Start: July 6, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)