RecruitingNot ApplicableNCT05854706

The Effect of Theta-burst Stimulation on Serum BDNF

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

Sponsor

Taipei City Hospital

Enrollment

60 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Conditions

Gambling Disorder

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.

Eligibility

Min Age: 20 YearsMax Age: 65 Years

Inclusion Criteria2

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

Exclusion Criteria9

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.