Gambling DisorderNCT05854706
The Effect of Theta-burst Stimulation on Serum BDNF
A study testing Theta Burst Stimulation in people with Gambling Disorder, run by Taipei City Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Apr 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei City Hospital
Taipei, Taipei CITY, 105
Hu-Ming Chang, 0978052951, DAU66@tpech.gov.tw
About this study
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
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.
Read the 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.
- Conditions
- Gambling Disorder
- Being tested
- Theta Burst Stimulation
- Keywords
- Brain-Derived Neurotrophic Factor, Theta Burst Stimulation
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta Burst StimulationDevice
Theta Burst Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Experimental | Prolonged iTBS sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks Receives: 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 Receives: Device: Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression severity
Measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: Before intervention (week 0) and after intervention (week 2)
Secondary outcomes (1)
Change in brain-derived neurotrophic factor (BDNF)
Serum level of BDNF
Measured: Before intervention (week 0) and after intervention (week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start17 Apr 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854706
- Sponsor's protocol ID
- TCHIRB-11003020
- Status last verified
- Feb 2023
- First submitted
- 18 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05854706
- Acronym / sponsor ID
- TCHIRB-11003020
- Conditions
- Gambling Disorder
- Keywords
- Brain-Derived Neurotrophic Factor, Theta Burst Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Experimental | Device: Theta Burst StimulationProlonged iTBS sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks |
| Sham arm | Sham comparator | Device: Theta Burst StimulationSham stimulation sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theta Burst StimulationTheta Burst Stimulation | Device | Active arm, Sham arm |
Primary outcome
Change in depression severity
Time frame: Before intervention (week 0) and after intervention (week 2)
Measured by Montgomery-Asberg Depression Rating Scale (MADRS)
1 secondary outcome
Change in brain-derived neurotrophic factor (BDNF)
Time frame: Before intervention (week 0) and after intervention (week 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta Burst Stimulation in people with Gambling Disorder, run by Taipei City Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu-Ming Chang (0978052951, DAU66@tpech.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression severity (time frame: Before intervention (week 0) and after intervention (week 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.