DepressionNCT04364880
Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression
A study testing TBS in people with Depression and Treatment, run by National Science and Technology Council, Taiwan.
Trial summary
This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression, Treatment
- What is being tested?
- TBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnostic criteria of DSM-IV for MDD
- The range of the age from 18 to 70-year-old
- Physically healthy on medical history, physical examination, and laboratory parameters within normal limits
- Competent for a full explanation of the study and written informed consent is obtained.
Who cannot join
- Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded
- Pregnant
- History or family history of seizure disorder
- Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain
- Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)
About this study
This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.
Read the detailed description
This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.
- Conditions
- Depression, Treatment
- Being tested
- TBS, Sham
- Keywords
- depression, transcranial magnetic stimulation, theta-burst stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBSDevice
Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)
ShamDevice
The sham-TBS coil produced a similar sound without a magnetic pulse.
| Study group | Role | What they receive |
|---|---|---|
| Theta-burst stimulation (TBS) | Experimental | Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS) Receives: Device: TBS |
| Sham controlled intervention | Sham comparator | The sham-TBS coil produced a similar sound without a magnetic pulse. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAMD)
The Hamilton Depression scale sum score (HAMD21)
- Not depressed: 0-7
- Mild: 8-13
- Moderate: 14-18
- Severe: 19-22
- Very severe: >23
Measured: From Weeks 0 to 24
Secondary outcomes (2)
Response rate
The decreasing level of the Hamilton Rating Scale for Depression from 0% to 50% compared to the sham group.
Measured: From Weeks 0 to 24
Remission rate
The higher scores on the Hamilton Rating Scale for Depression down to 8 points would be considered remission.
Measured: From Weeks 0 to 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Jan 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kuan-Pin, National Science and Technology Council, Taiwan
- Investigators
- Kuan-Pin Su, MD PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364880
- Sponsor's protocol ID
- NHRI-EX101-10144NI
- Status last verified
- Oct 2022
- First submitted
- 23 Apr 2020
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression
- ClinicalTrials.gov ID
- NCT04364880
- Acronym / sponsor ID
- NHRI-EX101-10144NI
- Conditions
- Depression, Treatment
- Keywords
- depression, transcranial magnetic stimulation, theta-burst stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 28 Apr 2020 (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.
This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.
Detailed description
This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theta-burst stimulation (TBS) | Experimental | Device: TBSTheta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS) |
| Sham controlled intervention | Sham comparator | Device: ShamThe sham-TBS coil produced a similar sound without a magnetic pulse. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The diagnostic criteria of DSM-IV for MDD
- The range of the age from 18 to 70-year-old
- Physically healthy on medical history, physical examination, and laboratory parameters within normal limits
- Competent for a full explanation of the study and written informed consent is obtained.
Key exclusion criteria (5 listed)
- Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded
- Pregnant
- History or family history of seizure disorder
- Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain
- Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)
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 |
|---|---|---|
| TBSTheta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS) | Device | Theta-burst stimulation (TBS) |
| ShamThe sham-TBS coil produced a similar sound without a magnetic pulse. | Device | Sham controlled intervention |
Primary outcome
Hamilton Rating Scale for Depression (HAMD)
Time frame: From Weeks 0 to 24
The Hamilton Depression scale sum score (HAMD21) * Not depressed: 0-7 * Mild: 8-13 * Moderate: 14-18 * Severe: 19-22 * Very severe: >23
2 secondary outcomes
Response rate
Time frame: From Weeks 0 to 24
Remission rate
Time frame: From Weeks 0 to 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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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.
Kuan-Pin Su, MD PhD principal investigator
China Medical University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TBS in people with Depression and Treatment, run by National Science and Technology Council, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (HAMD) (time frame: From Weeks 0 to 24). 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 10 Oct 2022.