Investigating the effects of theta burst stimulation on brain-derived neurotrophic factor levels in depression

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

This study is testing if a new brain stimulation technique can increase a specific protein in people with major depression to see if it helps improve their mood.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 20 Years to 65 Years
• Sex: All
• Sponsor: Taipei City Hospital (Government)
• Locations: 1 site (Taipei, Taipei CITY)
• Trial ID: NCT05854706 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to explore the impact of theta burst stimulation (TBS) on serum brain-derived neurotrophic factor (BDNF) levels in individuals diagnosed with major depressive disorder (MDD). Participants will be randomly assigned to either an active TBS group or a sham group, with the study measuring BDNF levels before and after treatment. The trial consists of 10 sessions of TBS administered over two weeks, with assessments conducted at baseline, after two weeks of treatment, and at a two-week follow-up. The study seeks to clarify the relationship between TBS and BDNF, which may play a role in the antidepressant effects of brain stimulation therapies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 20 to 65 who meet the DSM-5 criteria for major depressive disorder.

Not a fit: Patients with major psychiatric illnesses, unstable medical conditions, or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel and rapid treatment option for patients with major depressive disorder by enhancing BDNF levels.

How similar studies have performed: While there is evidence supporting the efficacy of repetitive transcranial magnetic stimulation, the specific application of theta burst stimulation in this context is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Inability to provide informed consent or comprehend the study procedure;
2. A major psychiatric illness including schizophrenia spectrum disorder, bipolar spectrum disorder, and major depressive disorder with psychotic features.
3. 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;
4. Have known preexisting noise-induced hearing loss, concurrent treatment with ototoxic medications, or with cochlear implants.
5. 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
6. On medications known to lower seizure threshold (e.g., TCA, bupropion, clozapine)
7. Implants controlled by physiological signals, including pacemaker, implantable cardioverter defibrillator, cochlear implant.
8. Metallic objects in the head, including stenting, suture.
9. Elevated risk of seizure due to traumatic brain history, seizure history, and head trauma, intracranial lesion, and alcohol or benzodiazepines withdrawal syndrome, stimulant intoxication.

Where this trial is running

Taipei, Taipei CITY

• Taipei City Hospital — Taipei, Taipei CITY, Taiwan (Recruiting)

Study contacts

• Study coordinator: Hu-Ming Chang

Conditions Gambling Disorder; Brain-Derived Neurotrophic Factor, Theta Burst Stimulation