The Effect of Theta-burst Stimulation on Serum BDNF
ConditionGambling Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorTaipei City Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Theta Burst Stimulation
DeviceTheta Burst Stimulation
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active armExperimental treatment 1 intervention
Group B: Sham armSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in depression severity
Measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame
Before intervention (week 0) and after intervention (week 2)Secondary outcomes
1
Change in brain-derived neurotrophic factor (BDNF)
Serum level of BDNF
Time frame
Before intervention (week 0) and after intervention (week 2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov