NCT05390593

Brief Summary

The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

May 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

April 13, 2022

Last Update Submit

May 20, 2022

Conditions

Depressive Disorder, Treatment-Resistant

Keywords

Repetitive transcranial magnetic stimulationMood Disorders

Outcome Measures

Primary Outcomes (3)

  • Change in 17-item Hamilton Depression Rating Scale

    17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression)

    Baseline, Week 1, Week 2, Week 4

  • Change in Montgomery-Asberg Depression Rating Scale

    Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression)

    Baseline, Week 1, Week 2, Week 4

  • Change in Beck Anxiety Inventory

    Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey)

    Baseline, Week 1, Week 2, Week 4

Secondary Outcomes (10)

  • Response rate after 2-week treatment at the end of iTBS (HDRD-17 )

    Baseline, Week 1, Week 2, Week 4

  • Response rate after 2-week treatment at the end of iTBS (MADRS)

    Baseline, Week 1, Week 2, Week 4

  • Changes in Clinical Global Index Severity

    Baseline, Week 1, Week 2, Week 4

  • Changes in Heart Rate Variability (HRV) band

    Baseline, Week 1, Day 3, Week 2, Week 4

  • Changes in EEG band

    Baseline, Week 1, Day 3, Week 2, Week 4

  • +5 more secondary outcomes

Study Arms (2)

iTBS-1800

EXPERIMENTAL

The active group will receive 1800 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.

Device: iTBS-1800

iTBS-1200

EXPERIMENTAL

The active group will receive 1200 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.

Device: iTBS-1200

Interventions

iTBS-1800DEVICE

Participants in the 1800-pulse intermittent TBS (iTBS-1800) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \& More stimulator.

iTBS-1800
iTBS-1200DEVICE

Participants in the 1200-pulse intermittent TBS (iTBS-1200) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \& More stimulator.

iTBS-1200

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The diagnosis of major depressive disorder according to DSM-5
  • Total HAM-D17 score of greater than or equal to 18 and Item 3 score less than 4 at screening visit. CGI-S score less than 4.
  • Before treatment, patient have to stop antidepressant for at least 1 weeks.
  • Capable and willing to provide informed consent.

You may not qualify if:

  • Have a concomitant major, unstable medical or neurologic illness :
  • Psychiatric disorder: Schizoprenia, Bipolar disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, substance use disorder.
  • Severe brian disease: Brain tumor, encephalitis, brian injury.
  • Intracranial implant and other ferromagnetic materials close to the head.
  • History of Seizures.
  • Cardiac pacemaker.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChangGungMH

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantMood Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMental Disorders

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
Psychiatry Department

Study Record Dates

First Submitted

April 13, 2022

First Posted

May 25, 2022

Study Start

August 1, 2021

Primary Completion

April 30, 2023

Study Completion

July 31, 2023

Last Updated

May 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)