Treatment-resistant DepressionNCT05422417
Dorsomedial Prefrontal Neuromodulation in Treatment-resistant Depression
A study testing Prolonged intermittent theta burst stimulation (piTBS) and 20Hz rTMS in people with Treatment-resistant Depression and Major Depressive Disorder, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Major depressive disorder (MDD) is a common and troublesome disorder, with high risk of physical and psychiatric comorbidity. At least one-third of patients could not achieve a response after several antidepressant trials, so-called treatment-refractory depression (TRD). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Treatment-resistant Depression, Major Depressive Disorder
- What is being tested?
- Prolonged intermittent theta burst stimulation (piTBS) and 20Hz rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jun 2022to 31 Dec 2025
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with a recurrent major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. Diagnoses were established after taking a thorough medical history and conducting a semistructured interview by administering the Mini International Neuropsychiatric Interview (MINI);
- Recruited participants had to have a Clinical Global Impression - Severity score of at least four and a total score of at least 18 on the 17-items Hamilton Depression Rating Scale (HDRS-17);
- Patients were qualified if they failed to respond to at least one adequate antidepressant treatment in their current episode (for example, failed to achieve 50% improvement of depression to an equivalent daily dose of 10 to 20 mg of escitalopram for at least eight weeks);
- Stabilized treatment: keeping current antidepressant drug treatment, including the dose at least for four weeks before this trial and during the trial period; keep the stabilized psychotherapy at least for three months and no anticipated adjustment of types of psychotherapy and the frequency.
Who cannot join
- Patients with Bipolar I and II disorder, schizophrenia, organic brain syndromes, or other major physical illnesses;
- Patients who had received or will receive brain surgery or receive brain metal implantation (for example, neurostimulator) or received cardiac pacemakers;
- Patients who had strong suicidal ideation within one week ( 3 points for third item of HDRS-suicidality)
- Patients who had abnormal finding in the brain ( for example, brain tumor or arteriovenous malformation) or neurological disease ( for example, history of meningitis, encephalitis, epilepsy, stroke or neurodegenerative disease)
- Pregnancy;
- Patients who have metal implantation in the body, including cochlear implant, prosthetic heart valve, neurostimulator, clips.. etc
Show all 9Show fewer
- Patients who also failed to respond after receiving one completed course of electroconvulsive therapy (ECT) treatment or left dorsolateral prefrontal brain stimulation (adequate dose and adequate duration of ECT or DLPFC-rTMS and had followed up to monitor the efficacy at least for three months)
- Claustrophobia for MRI screening;
- Those who cannot follow the protocols, and did not sign informed consent proved by the institutional review board (IRB)
Trial locations and contacts
1 site in 1 country.
Chih-Ming Cheng, M.D. contact
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital, Taiwan
Taipei
Chih-Ming Cheng, M.D., 886 2 28757027, vdodaco@gmail.com
About this study
Official title: New Form of Brain Stimulation Targeting Dorsomedial Prefrontal Cortex in Treating Refractory Depression and the Predictive Biomarkers of Antidepressant Efficacy
Major depressive disorder (MDD) is a common and troublesome disorder, with high risk of physical and psychiatric comorbidity. At least one-third of patients could not achieve a response after several antidepressant trials, so-called treatment-refractory depression (TRD). The high-frequency repetitive transcranial magnetic stimulation (rTMS) or intermittent theta-burst stimulation (iTBS) at left-sided dorsolateral prefrontal cortex (DLPFC) have a response rate of 40-60%. Obviously, not all TRD patients achieve the remitted state after treatment with antidepressants or DLPFC-rTMS, which may result from the heterogeneity of MDD. More and more evidence, such as brain lesion studies, deep brain stimulation, open-labeled rTMS case series, and neuroimaging studies, suggests that dorsomedial prefrontal cortex (DMPFC) might play a more central role in the pathophysiology of major depression. The DMPFC demonstrated as a "dorsal nexus" phenomenon in depression, which means a unique brain region where cortical networks for affect regulation, default mode control and cognitive control coverage in depressed subjects but not in healthy persons. In addition, another meta-analysis of resting-state functional MRI (fMRI) demonstrated the abnormal functional connectivity from DMPFC. These abnormalities of networks were highly associated with several depressive symptoms such as anhedonia, emotional regulation, somatic markers, rumination, self-reflection, poor attention and poor decision-making. However, only a handful of studies investigated the brain stimulation targeting DMPFC and the further changes in brain functional connectivity. The clinical efficacy and the fMRI changes of prolonged intermittent theta-burst stimulation (piTBS) and 20Hz- rTMS targeting bilateral DMPFC were investigated, and the predictive value of baseline networks by fMRI for antidepressant responses was also assessed to find a reliable approach to gauge treatment response prospectively.
Read the detailed description
Several open label studies showed the preliminary clinical efficacy of DMPFC stimulation, but there was no randomized sham-control trial to confirm the clinical efficacy in Asian people. In addition, there were also few fMRI studies to express the brain circuit changes after DMPFC stimulation. The clinical efficacy and the fMRI changes of prolonged intermittent theta-burst stimulation (piTBS) and 20Hz- rTMS targeting bilateral DMPFC were investigated, and the predictive value of baseline networks by fMRI for antidepressant responses was also assessed to find a reliable approach to gauge treatment response prospectively. All patients with TRD who failed at least one antidepressant trial are randomized to three groups (Group-A: piTBS treatment; Group-B: 20Hz-rTMS treatment; Group-C: sham treatment). Before and after 20 sessions targeting bilateral DMPFC over ten days, structural and functional magnetic resonance imaging (MRI) is arranged for each participant. In addition, pre- and post-treatment fMRI data are analyzed for each patient to investigate the networks and local brain activity changes between groups.
- Being tested
- Prolonged intermittent theta burst stimulation (piTBS), 20Hz rTMS, sham control
- Keywords
- rTMS, prolonged iTBS, brain stimulation, intermittent theta burst stimulation
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged intermittent theta burst stimulation (piTBS)Device
Participants in the prolonged dosage (1800 pulse) of intermittent TBS (iTBS) active stimulation group will receive 2-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to the bilateral DMPFC, twice a day. Stimulation will be delivered to the DMPFC using a stimulator.
20Hz rTMSDevice
Participants in the 20 Hz rTMS (2000 pulse) active stimulation group will receive 2-week 2s- and-10s off, total 50 cycles at each hemisphere/session, at an intensity of 100% resting motor threshold (MT) to the bilateral DMPFC, twice a day. Stimulation will be delivered to the DMPFC using a stimulator.
sham controlDevice
Half of the patients in the sham group received 2-week the same prolonged iTBS parameter stimulation (sham- prolonged iTBS), and the other half received the same 20 Hz rTMS parameter stimulation using a sham coil (sham-20 Hz rTMS), which also improved the blinding process
| Study group | Role | What they receive |
|---|---|---|
| Prolonged intermittent theta-burst(iTBS)-DMPFC | Experimental | This active group will receive prolonged intermittent theta-burst(iTBS) on the dorsomedial prefrontal cortex(DMPFC) Receives: Device: Prolonged intermittent theta burst stimulation (piTBS) |
| 20Hz rTMS-DMPFC | Experimental | This active group will receive 20Hz rTMS on the DMPFC Receives: Device: 20Hz rTMS |
| Sham prolonged iTBS-DMPFC or 20Hz rTMS-DMPFC | Sham comparator | Patients in the sham group will receive the same prolonged iTBS or 20Hz rTMS performed by a sham coil. Receives: Device: sham control |
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
the altered 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
Measured: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Change in anxiosomatic cluster symptoms derived 17-item Hamilton Depression Rating Scale
the altered anxiosomatic cluster symptoms (range, 0 to 26, with higher scores indicating more severe anxiosomatic symptoms).The anxiosomatic cluster symptoms comprised nine items derived from HDRS-17: early insomnia, middle insomnia, slowness or retardation, psychic anxiety, autonomic anxiety, gastrointestinal symptoms, somatic symptoms, genital symptoms, and hypochondriasis.
Measured: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Secondary outcomes (22)
Response rate after 2-week treatment at the end of the trial, one month and three months after.
Improvement ≥ 50 % of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
Measured: Time Frame: Week 2, Week 6(one month after brain stimulation), Week 14(three-month after brain stimulation)
Remission rate after 2-week treatment at the end of the trial, one month and three months after.
17-item Hamilton Depression Rating Scale ≤7 (range, 0 to 52, with higher scores indicating more depression)
Measured: Time Frame: Week 2, Week 6(one month after brain stimulation), Week 14(three-month after brain stimulation)
Changes in Clinical Global Index
Clinical Global Index, range from 1 to 7 with higher scores indicating worse clinical severity of illness.
Measured: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Changes in depression severity, rated by self-reported
including Depression and Somatic Symptoms sub-scales, range from 0 to 66 with higher scores indicating more depressive and somatic symptom.
Measured: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Changes in Young Mania Rating Scale
Young Mania Rating Scale, range from 0 to 60 with higher scores indicating more severe manic symptoms.
Measured: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Baseline treatment refractory level and the further antidepressant efficacy of brain stimulation
Maudsley staging method(MSM),, range from 3 to 15 with higher scores indicating higher treatment resistance.
Measured: Baseline and Week 2
Baseline treatment refractory level(TRDSS) and the further antidepressant efficacy of brain stimulation
Treatment-resistant depression severity scale(TRDSS), range from 3 to 20 with higher scores indicating higher treatment resistance.
Measured: Baseline and Week 2
Baseline Life event stress scale and the further clinical efficacy of brain stimulation
Life event stress scale,range from 0 to 1467 with higher scores indicating more life event stress.
Measured: Baseline and Week 2
Changes in depression severity, rated by Montgomery-Asberg Depression Rating Scale (MADRS)
the altered MADRS (range, 0 to 60 , with higher scores representing greater severity of depressive symptoms.
Measured: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Change in Hamilton Anxiety Scale (HAMA)
the altered Hamilton Anxiety Scale (HAMA) (range, 0 to 56, with higher scores indicating more anxiety)
Measured: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Baseline Rumination response scale (RRS) and the further clinical efficacy of brain stimulation
RRS,range from 22 to 88 with higher scores indicating more rumination.
Measured: Baseline and Week 2
Change in Rumination response scale (RRS)
RRS,range from 22 to 88 with higher scores indicating more rumination.
Measured: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Baseline Snaith-Hamilton Pleasure Scale and the further clinical efficacy of brain stimulation
The 14-item Snaith-Hamilton Pleasure Scale is a self-administered instrument. Each of the items has a set of four response categories--Definitely Agree, Agree, Disagree, and Strongly Disagree, with either of the Disagree responses receiving a score of 1 and either of the Agree responses receiving a score of 0. Thus, the SHAPS was scored as the sum of the 14 items so that total scores ranged from 0 to 14. A higher total SHAPS score indicated higher levels of present state of anhedonia.
Measured: Baseline and Week 2
Change in Snaith-Hamilton Pleasure Scale
The 14-item Snaith-Hamilton Pleasure Scale is a self-administered instrument. Each of the items has a set of four response categories--Definitely Agree, Agree, Disagree, and Strongly Disagree, with either of the Disagree responses receiving a score of 1 and either of the Agree responses receiving a score of 0. Thus, the SHAPS was scored as the sum of the 14 items so that total scores ranged from 0 to 14. A higher total SHAPS score indicated higher levels of present state of anhedonia.
Measured: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Changes in EEG band before and after brain stimulation
The value changes of prefrontal alpha, beta, theta, delta wave before and after 2 weeks treatment
Measured: Baseline and Week 2
Changes in brain connectivity before and after brain stimulation
the change in resting-state functional connectivity
Measured: Baseline and Week 2
Changes in TMS-EEG/paired-pulse stimulation before and after brain stimulation
the change in TMS-EEG/paired-pulse stimulation
Measured: Baseline and Week 2
Changes in cognitive performance of Taiwan Cognition Questionnaire
Evaluate by Taiwan Cognition Questionnaire, range from 0 to 15 with higher scores indicating higher cognitive impairment
Measured: Baseline and Week 2
Changes in cognitive performance of word list recall.
Evaluate by word list recall.
Measured: Baseline and Week 2
Changes in cognitive performance of Trail-Making Test
Evaluate by Trail-Making Test
Measured: Baseline and Week 2
Changes in cognitive performance of Go/No-Go task
Evaluate by Go/No-Go task
Measured: Baseline and Week 2
Changes in cognitive performance of Wisconsin Card Sorting Test
Evaluate by Wisconsin Card Sorting Test
Measured: Baseline and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start7 Jun 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant DepressionStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chih-Ming Cheng, M.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422417
- Sponsor's protocol ID
- IRB-TPEVGH No.: 2021-08-006A#1
- Status last verified
- Aug 2022
- First submitted
- 7 Jun 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Form of Brain Stimulation Targeting Dorsomedial Prefrontal Cortex in Treating Refractory Depression and the Predictive Biomarkers of Antidepressant Efficacy
- ClinicalTrials.gov ID
- NCT05422417
- Acronym / sponsor ID
- IRB-TPEVGH No.: 2021-08-006A#1
- Keywords
- rTMS, prolonged iTBS, brain stimulation, intermittent theta burst stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jun 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.
Major depressive disorder (MDD) is a common and troublesome disorder, with high risk of physical and psychiatric comorbidity. At least one-third of patients could not achieve a response after several antidepressant trials, so-called treatment-refractory depression (TRD). The high-frequency repetitive transcranial magnetic stimulation (rTMS) or intermittent theta-burst stimulation (iTBS) at left-sided dorsolateral prefrontal cortex (DLPFC) have a response rate of 40-60%. Obviously, not all TRD patients achieve the remitted state after treatment with antidepressants or DLPFC-rTMS, which may result from the heterogeneity of MDD. More and more evidence, such as brain lesion studies, deep brain stimulation, open-labeled rTMS case series, and neuroimaging studies, suggests that dorsomedial prefrontal cortex (DMPFC) might play a more central role in the pathophysiology of major depression. The DMPFC demonstrated as a "dorsal nexus" phenomenon in depression, which means a unique brain region where cortical networks for affect regulation, default mode control and cognitive control coverage in depressed subjects but not in healthy persons. In addition, another meta-analysis of resting-state functional MRI (fMRI) demonstrated the abnormal functional connectivity from DMPFC. These abnormalities of networks were highly associated with several depressive symptoms such as anhedonia, emotional regulation, somatic markers, rumination, self-reflection, poor attention and poor decision-making. However, only a handful of studies investigated the brain stimulation targeting DMPFC and the further changes in brain functional connectivity. The clinical efficacy and the fMRI changes of prolonged intermittent theta-burst stimulation (piTBS) and 20Hz- rTMS targeting bilateral DMPFC were investigated, and the predictive value of baseline networks by fMRI for antidepressant responses was also assessed to find a reliable approach to gauge treatment response prospectively.
Detailed description
Several open label studies showed the preliminary clinical efficacy of DMPFC stimulation, but there was no randomized sham-control trial to confirm the clinical efficacy in Asian people. In addition, there were also few fMRI studies to express the brain circuit changes after DMPFC stimulation. The clinical efficacy and the fMRI changes of prolonged intermittent theta-burst stimulation (piTBS) and 20Hz- rTMS targeting bilateral DMPFC were investigated, and the predictive value of baseline networks by fMRI for antidepressant responses was also assessed to find a reliable approach to gauge treatment response prospectively. All patients with TRD who failed at least one antidepressant trial are randomized to three groups (Group-A: piTBS treatment; Group-B: 20Hz-rTMS treatment; Group-C: sham treatment). Before and after 20 sessions targeting bilateral DMPFC over ten days, structural and functional magnetic resonance imaging (MRI) is arranged for each participant. In addition, pre- and post-treatment fMRI data are analyzed for each patient to investigate the networks and local brain activity changes between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prolonged intermittent theta-burst(iTBS)-DMPFC | Experimental | Device: Prolonged intermittent theta burst stimulation (piTBS)This active group will receive prolonged intermittent theta-burst(iTBS) on the dorsomedial prefrontal cortex(DMPFC) |
| 20Hz rTMS-DMPFC | Experimental | Device: 20Hz rTMSThis active group will receive 20Hz rTMS on the DMPFC |
| Sham prolonged iTBS-DMPFC or 20Hz rTMS-DMPFC | Sham comparator | Device: sham controlPatients in the sham group will receive the same prolonged iTBS or 20Hz rTMS performed by a sham coil. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with a recurrent major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. Diagnoses were established after taking a thorough medical history and conducting a semistructured interview by administering the Mini International Neuropsychiatric Interview (MINI);
- Recruited participants had to have a Clinical Global Impression - Severity score of at least four and a total score of at least 18 on the 17-items Hamilton Depression Rating Scale (HDRS-17);
- Patients were qualified if they failed to respond to at least one adequate antidepressant treatment in their current episode (for example, failed to achieve 50% improvement of depression to an equivalent daily dose of 10 to 20 mg of escitalopram for at least eight weeks);
- Stabilized treatment: keeping current antidepressant drug treatment, including the dose at least for four weeks before this trial and during the trial period; keep the stabilized psychotherapy at least for three months and no anticipated adjustment of types of psychotherapy and the frequency.
Key exclusion criteria (9 listed)
- Patients with Bipolar I and II disorder, schizophrenia, organic brain syndromes, or other major physical illnesses;
- Patients who had received or will receive brain surgery or receive brain metal implantation (for example, neurostimulator) or received cardiac pacemakers;
- Patients who had strong suicidal ideation within one week ( 3 points for third item of HDRS-suicidality)
- Patients who had abnormal finding in the brain ( for example, brain tumor or arteriovenous malformation) or neurological disease ( for example, history of meningitis, encephalitis, epilepsy, stroke or neurodegenerative disease)
- 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 |
|---|---|---|
| Prolonged intermittent theta burst stimulation (piTBS)Participants in the prolonged dosage (1800 pulse) of intermittent TBS (iTBS) active stimulation group will receive 2-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to the bilateral DMPFC, twice a day. Stimulation will be delivered to the DMPFC using a stimulator. | Device | Prolonged intermittent theta-burst(iTBS)-DMPFC |
| 20Hz rTMSParticipants in the 20 Hz rTMS (2000 pulse) active stimulation group will receive 2-week 2s- and-10s off, total 50 cycles at each hemisphere/session, at an intensity of 100% resting motor threshold (MT) to the bilateral DMPFC, twice a day. Stimulation will be delivered to the DMPFC using a stimulator. | Device | 20Hz rTMS-DMPFC |
| sham controlHalf of the patients in the sham group received 2-week the same prolonged iTBS parameter stimulation (sham- prolonged iTBS), and the other half received the same 20 Hz rTMS parameter stimulation using a sham coil (sham-20 Hz rTMS), which also improved the blinding process | Device | Sham prolonged iTBS-DMPFC or 20Hz rTMS-DMPFC |
Primary outcome
Change in 17-item Hamilton Depression Rating Scale
Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
the altered 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
Change in anxiosomatic cluster symptoms derived 17-item Hamilton Depression Rating Scale
Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
the altered anxiosomatic cluster symptoms (range, 0 to 26, with higher scores indicating more severe anxiosomatic symptoms).The anxiosomatic cluster symptoms comprised nine items derived from HDRS-17: early insomnia, middle insomnia, slowness or retardation, psychic anxiety, autonomic anxiety, gastrointestinal symptoms, somatic symptoms, genital symptoms, and hypochondriasis.
22 secondary outcomes
Response rate after 2-week treatment at the end of the trial, one month and three months after.
Time frame: Time Frame: Week 2, Week 6(one month after brain stimulation), Week 14(three-month after brain stimulation)
Remission rate after 2-week treatment at the end of the trial, one month and three months after.
Time frame: Time Frame: Week 2, Week 6(one month after brain stimulation), Week 14(three-month after brain stimulation)
Changes in Clinical Global Index
Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Changes in depression severity, rated by self-reported
Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Changes in Young Mania Rating Scale
Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Baseline treatment refractory level and the further antidepressant efficacy of brain stimulation
Time frame: Baseline and Week 2
Baseline treatment refractory level(TRDSS) and the further antidepressant efficacy of brain stimulation
Time frame: Baseline and Week 2
Baseline Life event stress scale and the further clinical efficacy of brain stimulation
Time frame: Baseline and Week 2
Changes in depression severity, rated by Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Change in Hamilton Anxiety Scale (HAMA)
Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Baseline Rumination response scale (RRS) and the further clinical efficacy of brain stimulation
Time frame: Baseline and Week 2
Change in Rumination response scale (RRS)
Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Baseline Snaith-Hamilton Pleasure Scale and the further clinical efficacy of brain stimulation
Time frame: Baseline and Week 2
Change in Snaith-Hamilton Pleasure Scale
Time frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)
Changes in EEG band before and after brain stimulation
Time frame: Baseline and Week 2
Changes in brain connectivity before and after brain stimulation
Time frame: Baseline and Week 2
Changes in TMS-EEG/paired-pulse stimulation before and after brain stimulation
Time frame: Baseline and Week 2
Changes in cognitive performance of Taiwan Cognition Questionnaire
Time frame: Baseline and Week 2
Changes in cognitive performance of word list recall.
Time frame: Baseline and Week 2
Changes in cognitive performance of Trail-Making Test
Time frame: Baseline and Week 2
Changes in cognitive performance of Go/No-Go task
Time frame: Baseline and Week 2
Changes in cognitive performance of Wisconsin Card Sorting Test
Time frame: Baseline and Week 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
Chih-Ming Cheng, M.D. contact
Chih-Ming Cheng, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged intermittent theta burst stimulation (piTBS) and 20Hz rTMS in people with Treatment-resistant Depression and Major Depressive Disorder, run by Taipei Veterans General Hospital, Taiwan 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 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 17 Aug 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. 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 Chih-Ming Cheng, M.D. (+886 2 28757027, vdodaco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 17-item Hamilton Depression Rating Scale (time frame: Time Frame: Baseline, Week 1, Week 2, Week 3 (one week after brain stimulation), Week 6, Week 14(three-month after brain stimulation)). The study lists 2 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 17 Aug 2022.