Depressive Disorder, Treatment-ResistantiTBSNCT05390593
Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation
A study testing iTBS-1800 and iTBS-1200 in people with Depressive Disorder, Treatment-Resistant, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- What is being tested?
- iTBS-1800 and iTBS-1200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Jul 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of major depressive disorder according to DSM-5
- Total HAM-D17 score of greater than or equal to 18 and Item 3 score less than 4 at screening visit. CGI-S score less than 4.
- Before treatment, patient have to stop antidepressant for at least 1 weeks.
- Capable and willing to provide informed consent.
Who cannot join
- Have a concomitant major, unstable medical or neurologic illness :
- Psychiatric disorder: Schizoprenia, Bipolar disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, substance use disorder.
- Severe brian disease: Brain tumor, encephalitis, brian injury.
- Intracranial implant and other ferromagnetic materials close to the head.
- History of Seizures.
- Cardiac pacemaker.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation: a Three-track Approach in Affective Computing, Randomized Controlled Trial, and Meta-analysis
The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.
- Conditions
- Depressive Disorder, Treatment-Resistant
- Being tested
- iTBS-1800, iTBS-1200
- Keywords
- Repetitive transcranial magnetic stimulation, Mood Disorders
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBS-1800Device
Participants in the 1800-pulse intermittent TBS (iTBS-1800) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \& More stimulator.
iTBS-1200Device
Participants in the 1200-pulse intermittent TBS (iTBS-1200) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \& More stimulator.
| Study group | Role | What they receive |
|---|---|---|
| iTBS-1800 | Experimental | The active group will receive 1800 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex. Receives: Device: iTBS-1800 |
| iTBS-1200 | Experimental | The active group will receive 1200 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex. Receives: Device: iTBS-1200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 17-item Hamilton Depression Rating Scale
17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression)
Measured: Baseline, Week 1, Week 2, Week 4
Change in Montgomery-Asberg Depression Rating Scale
Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression)
Measured: Baseline, Week 1, Week 2, Week 4
Change in Beck Anxiety Inventory
Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey)
Measured: Baseline, Week 1, Week 2, Week 4
Secondary outcomes (10)
Response rate after 2-week treatment at the end of iTBS (HDRD-17 )
Improvement > 50 % of HDRD-17
Measured: Baseline, Week 1, Week 2, Week 4
Response rate after 2-week treatment at the end of iTBS (MADRS)
Improvement > 50 % of MADRS
Measured: Baseline, Week 1, Week 2, Week 4
Changes in Clinical Global Index Severity
Clinical Global Index
Measured: Baseline, Week 1, Week 2, Week 4
Changes in Heart Rate Variability (HRV) band
Heart rate variability measured by Wegene 8Z11
Measured: Baseline, Week 1, Day 3, Week 2, Week 4
Changes in EEG band
Changes in EEG band before and after brain stimulation. Subject EEG activity including EEG waveform, spectrum, spectrogram, and power in the slow (0.1-1 Hz), delta (1 to 4 Hz), theta (4 to 8 Hz), alpha (8 to 12 Hz), beta (12 to 25 Hz), and gamma (25 to 70 Hz) bands.
Measured: Baseline, Week 1, Day 3, Week 2, Week 4
Change in BDNF
Changes in BDNF values
Measured: Baseline, Week 2
Change in TSH
Change in TSH values
Measured: Baseline, Week 2
Change in T3
Change in T3
Measured: Baseline, Week 2
Change in T4
Change in T4
Measured: Baseline, Week 2
Change in cortisol
Change in cortisol
Measured: Baseline, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Aug 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, Treatment-ResistantStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Wei Hsu, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390593
- Sponsor's protocol ID
- CMRPG8L0871
- Acronym
- iTBS
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation: a Three-track Approach in Affective Computing, Randomized Controlled Trial, and Meta-analysis
- ClinicalTrials.gov ID
- NCT05390593
- Acronym / sponsor ID
- iTBS / CMRPG8L0871
- Conditions
- Depressive Disorder, Treatment-Resistant
- Keywords
- Repetitive transcranial magnetic stimulation, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 25 May 2022 (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 main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTBS-1800 | Experimental | Device: iTBS-1800The active group will receive 1800 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex. |
| iTBS-1200 | Experimental | Device: iTBS-1200The active group will receive 1200 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The diagnosis of major depressive disorder according to DSM-5
- Total HAM-D17 score of greater than or equal to 18 and Item 3 score less than 4 at screening visit. CGI-S score less than 4.
- Before treatment, patient have to stop antidepressant for at least 1 weeks.
- Capable and willing to provide informed consent.
Key exclusion criteria (7 listed)
- Have a concomitant major, unstable medical or neurologic illness :
- Intracranial implant and other ferromagnetic materials close to the head.
- History of Seizures.
- Cardiac pacemaker.
- Pregnancy.
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 |
|---|---|---|
| iTBS-1800Participants in the 1800-pulse intermittent TBS (iTBS-1800) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \& More stimulator. | Device | iTBS-1800 |
| iTBS-1200Participants in the 1200-pulse intermittent TBS (iTBS-1200) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \& More stimulator. | Device | iTBS-1200 |
Primary outcome
Change in 17-item Hamilton Depression Rating Scale
Time frame: Baseline, Week 1, Week 2, Week 4
17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression)
Change in Montgomery-Asberg Depression Rating Scale
Time frame: Baseline, Week 1, Week 2, Week 4
Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression)
Change in Beck Anxiety Inventory
Time frame: Baseline, Week 1, Week 2, Week 4
Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey)
10 secondary outcomes
Response rate after 2-week treatment at the end of iTBS (HDRD-17 )
Time frame: Baseline, Week 1, Week 2, Week 4
Response rate after 2-week treatment at the end of iTBS (MADRS)
Time frame: Baseline, Week 1, Week 2, Week 4
Changes in Clinical Global Index Severity
Time frame: Baseline, Week 1, Week 2, Week 4
Changes in Heart Rate Variability (HRV) band
Time frame: Baseline, Week 1, Day 3, Week 2, Week 4
Changes in EEG band
Time frame: Baseline, Week 1, Day 3, Week 2, Week 4
Change in BDNF
Time frame: Baseline, Week 2
Change in TSH
Time frame: Baseline, Week 2
Change in T3
Time frame: Baseline, Week 2
Change in T4
Time frame: Baseline, Week 2
Change in cortisol
Time frame: Baseline, Week 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS-1800 and iTBS-1200 in people with Depressive Disorder, Treatment-Resistant, run by Chang Gung Memorial 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 4 inclusion and 7 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 25 May 2022. 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. 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?
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?
Change in 17-item Hamilton Depression Rating Scale (time frame: Baseline, Week 1, Week 2, Week 4). The study lists 3 primary outcomes in all. 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 25 May 2022.