Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT05854706
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2023-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Theta-burst Stimulation on Serum BDNF
Sponsor:
Taipei City Hospital
Organization:
Study Overview
Official Title:
Antidepressant Effect of Prolonged Intermittent Theta-burst Stimulation on Serum Brain-derived Neurotrophic Factor Levels of Patients With Depression: A Randomized, Double-Blind, Sham-Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Participants will be randomized into active group and sham group. Researchers will compare the level of BDNF in these groups.
Detailed Description:
There is an increasing evidence that the BDNF could be involved in the mode of action of antidepressants and, perhaps, of brain stimulation. Brain stimulation methods, such as electroconvulsive therapy (ECT) has been used to treat patients with severe depression and is reported to increase BDNF levels in blood. Numerous studies has demonstrated that repetitive transcranial magnetic stimulation (rTMS) as an alternative to ECT, produced the most robust antidepressant effects, and is the most widely applied treatment protocol for major depressive disorder (MDD). Theta-burst stimulation (TBS) is a novel form of rTMS, and has recently emerged as a method with the potential to produce similar anti-depressant effects much more rapidly than traditional repetitive TMS protocols. It is presumed that BDNF mediates the therapeutic benefits of brain rTMS, but previous results are contradictory.
Specific Aims:
The study is a four-week randomized, double-blind, sham-controlled study comparing pre- and post-treatment serum BDNF levels of patients with MDD, who receive active or sham of prolonged intermittent TBS (piTBS) treatment.
Method:
During the four-week double-blind phase of active or sham piTBS treatment, piTBS sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks. Symptomatic ratings and serum BDNF measurement are administered at baseline (W0, before brain stimulation), at the end of Week 2 brain stimulation treatments, and at the two-week follow-up after the treatment (Week 4). Otherwise, the symptomatic changes are also evaluated at the end of Week 1 brain stimulation. The study include sixty patients with major depression and all participants are randomly allocated (1:1) to groups receiving either active or sham piTBS group. The aim of the present study is to explore the effect of piTBS therapy on serum BDNF levels and change of depression symptom rating scale, as well as their associations in patients with MDD.
Specific Aims:
The study is a four-week randomized, double-blind, sham-controlled study comparing pre- and post-treatment serum BDNF levels of patients with MDD, who receive active or sham of prolonged intermittent TBS (piTBS) treatment.
Method:
During the four-week double-blind phase of active or sham piTBS treatment, piTBS sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks. Symptomatic ratings and serum BDNF measurement are administered at baseline (W0, before brain stimulation), at the end of Week 2 brain stimulation treatments, and at the two-week follow-up after the treatment (Week 4). Otherwise, the symptomatic changes are also evaluated at the end of Week 1 brain stimulation. The study include sixty patients with major depression and all participants are randomly allocated (1:1) to groups receiving either active or sham piTBS group. The aim of the present study is to explore the effect of piTBS therapy on serum BDNF levels and change of depression symptom rating scale, as well as their associations in patients with MDD.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: