NCT05854706

Brief Summary

The goal of this clinical trial is to investigate the effect of theta burst stimulation for depression and serum brain-derived neurotrophic factor (BDNF) in individuals with major depression. The main question it aims to answer is whether 10 sessions of theta burst stimulation can influence the serum level of BDNF. Participants will be randomized into active group and sham group. Researchers will compare the level of BDNF in these groups.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress98%
Apr 2023Jun 2026

Study Start

First participant enrolled

April 17, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 11, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

April 18, 2023

Last Update Submit

May 2, 2023

Conditions

Gambling Disorder

Keywords

Brain-Derived Neurotrophic Factor, Theta Burst Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in depression severity

    Measured by Montgomery-Asberg Depression Rating Scale (MADRS)

    Before intervention (week 0) and after intervention (week 2)

Secondary Outcomes (1)

  • Change in brain-derived neurotrophic factor (BDNF)

    Before intervention (week 0) and after intervention (week 2)

Study Arms (2)

Active arm

EXPERIMENTAL

Prolonged iTBS sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks

Device: Theta Burst Stimulation

Sham arm

SHAM COMPARATOR

Sham stimulation sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks

Device: Theta Burst Stimulation

Interventions

Theta Burst StimulationDEVICE

Theta Burst Stimulation

Active armSham arm

Eligibility Criteria

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

You may qualify if:

  • age between 20 and 65 years;
  • fulfilling the Diagnostic and Statistical Manual version 5 (DSM-5) criteria of Major depressive disorder assessed by the Structured Clinical Interview

You may not qualify if:

  • Inability to provide informed consent or comprehend the study procedure;
  • A major psychiatric illness including schizophrenia spectrum disorder, bipolar spectrum disorder, and major depressive disorder with psychotic features.
  • A current DSM-5 diagnosis of substance use disorder except nicotine use disorder or the use of one to two low-potency benzodiazepine tablets for sleep impairment;
  • Have known preexisting noise-induced hearing loss, concurrent treatment with ototoxic medications, or with cochlear implants.
  • Unstable medical illness, including malignancy, uncontrolled diabetes mellitus, unstable cardiac disease or recent myocardial infarction, or cerebrovascular or cardiovascular risk factors that require intensive medical management
  • On medications known to lower seizure threshold (e.g., TCA, bupropion, clozapine)
  • Implants controlled by physiological signals, including pacemaker, implantable cardioverter defibrillator, cochlear implant.
  • Metallic objects in the head, including stenting, suture.
  • Elevated risk of seizure due to traumatic brain history, seizure history, and head trauma, intracranial lesion, and alcohol or benzodiazepines withdrawal syndrome, stimulant intoxication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, Taipei CITY, 105, Taiwan

RECRUITING

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Central Study Contacts

Hu-Ming Chang

CONTACT

0978052951DAU66@tpech.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 11, 2023

Study Start

April 17, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 11, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)