DepressionNCT05117983
Non-invasive Brain Stimulation Normalizes Dopaminergic Transmission in the Frontostriatal Circuit to Alleviate Depression With Metabolic Disorders.
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Depression, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Depression and metabolic disorder (MetD) are two of the most common and debilitating disorders worldwide, occurring with significant rates of comorbidity. This is a major clinical challenge as the outcomes of both conditions are worsened. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Aug 2021to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- (1)Signed informed consent by patient or legal representative;
- (2) male or female patient aged ≧20 and ≦70 years;
- (3) a diagnosis of MDD or BD according to DSM criteria made by a specialist in psychiatry;
- (4) a total score of at least 18 in the Hamilton Rating Scale for Depression (HDRS) at the screening stage;
- (5) patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
Who cannot join
- (1) women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study;
- (2) females who are pregnant or breast-feeding;
- (3) other major DSM 5 diagnoses other than mood disorders, except for tobacco use disorder and anxiety disorder;
- (4) current evidence of an uncontrolled and/or clinically significant medical condition, e.g. patients with extensive area of ischemic bruise, multiple sclerosis, cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation;
- (5) history of seizure or epilepsy;
- (6) history of neurological diseases or traumatic brain injury;
Show all 12Show fewer
- (7) history of brain lesion, having received neurosurgery, meningitis or encephalitis;
- (8) exacerbation of symptom severity, presenting severe suicidal ideation or self harm behavior during the screen or study period;
- (9) presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators, magnetic cochlear prosthesis, intracranial/intraocular metallic fragments;
- (10) patient has received electroconvulsive therapy (ECT) within 3 months prior to the first intervention of the treatment;
- (11) skin lesion at local site receiving rTMS stimulation;
- (12) those who cannot tolerate the side effects or ever developed sleep disorder while receiving rTMS therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Depression and metabolic disorder (MetD) are two of the most common and debilitating disorders worldwide, occurring with significant rates of comorbidity. This is a major clinical challenge as the outcomes of both conditions are worsened. Studies have uncovered that depression and metabolic disorder are associated with chronic, low-grade inflammation. In brain circuit level, patients with depression are characterized with aberrant frontostriatal (FS) circuit connectivity and reduced activity level that also associated with metabolic comorbidity. In neurotransmitter level, the dopaminergic pathway, that could be feedback regulated by immune and metabolic factors, has long been known to involve in emotional and metabolic homeostasis. More importantly, this dopamine (DA) input is critical to shaping the FS circuit-level dynamic connectivity and plasticity. Therefore, this study hypothesizes that inflammatory and metabolic dysregulations on DA transmission link to the aberrant FS function that cause mood and metabolic syndromes. To clarify the underlying mechanisms, 90 patients who meet the DSM-5 diagnostic criteria of major depressive episode in either major depressive disorder or bipolar disorder are planned to be recruit. FS functional connectivity and activation, before and after receiving 10 Hz repetitive transcranial magnetic stimulation (rTMS) to left dorsolateral prefrontal cortex will be measured. Then systemically analyze participants' clinical symptomology, neurocognitive function, inflammation and metabolic status. Possible correlations between indices, the effects of rTMS and differences between groups will be tested. Results could provide a chance for further understanding the pathophysiology of depression with MetD and comparing between unipolar and bipolar depression, and developing brain circuit based non-invasive brain stimulation personalized treatment for depression with MetD to achieve a better outcome.
Read the detailed description
Depression and metabolic disorder (MetD) are two of the most common and debilitating disorders worldwide, occurring with significant rates of comorbidity. This is a major clinical challenge as the outcomes of both conditions are worsened. Studies have uncovered that depression and metabolic disorder are associated with chronic, low-grade inflammation. In brain circuit level, patients with depression are characterized with aberrant frontostriatal (FS) circuit connectivity and reduced activity level that also associated with metabolic comorbidity. BD patients also showed functional anomalies in the VS and FS circuits with reduced neural flexibility of hedonic signaling in response to stress. The dysfunctional FS circuits also link to the metabolic comorbidities in patients with mood disorders. Regarding metabolic control, the FS functional connectivity changes affect food craving. And the altered reciprocal loop from the medial prefrontal cortex could regulate eating behavior and metabolic disturbance. In neurotransmitter level, the dopaminergic pathway, that could be feedback regulated by immune and metabolic factors, has long been known to involve in emotional and metabolic homeostasis. More importantly, this dopamine (DA) input is critical to shaping the FS circuit-level dynamic connectivity and plasticity. Disruptions in the dopamine (DA) system have been observed in psychiatric disorders. MDD might involve DA reductions that could result from either diminished DA release from presynaptic neurons or impaired signal transduction, either due to changes in receptor number or function and/or altered intracellular signal processing. Therefore this study hypothesizes that inflammatory and metabolic dysregulations on DA transmission link to the aberrant FS function that cause depression and MetD. To clarify the underlying mechanisms, unipolar and bipolar depression patients will be enrolled to measure the FS functional connectivity and activation, before and after receiving 10 Hz repetitive transcranial magnetic stimulation (rTMS) to left dorsolateral prefrontal cortex. Then systemically analyze participants' clinical symptomology, neurocognitive function, inflammation and metabolic status. Possible correlations between indices, the effects of rTMS and the possible differences between unipolar and bipolar depression patients will be tested. Results could provide a chance for further understanding the pathophysiology and better treatment of depression with MetD, finding biomarkers for subgrouping depression between unipolar depression and bipolar depression, predicting outcomes to brain circuit based personalized rTMS treatment for depression with MetD.
The specific aims of the project are:
Aim 1: To find the biological homogeneousness among depression with MetD by investigate the associations between (1) FS circuit connectivity and clinical (mood and metabolic) symptoms, and (2) FS circuit activation and clinical (mood and metabolic) symptoms in both unipolar and bipolar depressed individuals.
Aim 2: To confirm the role of FS in depression with MetD by applying rTMS to test its effects on (1) clinical symptoms, (2) FS circuit activation, (3) FS circuit connectivity and (4) find predictors for the rTMS treatment response.
Aim 3: To study the bidirectional inflammatory and metabolic feedback regulations of the DA transmission in FS circuit in depression with MetD by investigate the associations between (1) FS circuit activation, and (2) FS circuit connectivity and systemic inflammatory/ metabolic regulators both before and after rTMS treatments.
- Conditions
- Depression
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Depression, Dopamine (DA), Frontostriatal (FS) circuit, Metabolic disorder, Repetitive transcranial magnetic stimulation (rTMS)
- Medical subject headings
- Depression, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Device
Also called Antidepressants
Real-time MRI-guided neuronavigation with a Visor neuronavigation system (ANT Neuro, Enschede, Netherlands) will be used for coil positioning. Left dorsolateral prefrontal cortex target is located in each participant.
| Study group | Role | What they receive |
|---|---|---|
| MDD patient with HRSD score of at least 18 | Active comparator | MDD patients who meet the DSM-5 diagnostic criteria of MDD and their current episode show a Hamilton Rating Scale for Depression (HRSD) score of at least 18 Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
| BD patient with HRSD score of at least 18 | Active comparator | BD patients who meet the DSM-5 diagnostic criteria of BD and their current depression episode show a Hamilton Rating Scale for Depression (HRSD) score of at least 18 Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline mood symptom severity at several timepoints over 3 months
Evaluation for disease severity by using the Hamilton Rating Scale for Depression (HAM-D) by trained senior psychiatrists. The same rater administers the scale for each patient.
Measured: Week 0, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12.
Iowa gambling task (IGT) with functional MR imaging
The subject will be asked to turn a card from 4-decks voluntarily, and maximize gains and minimize losses during the game.
Measured: Week 0
Change from baseline functional connectivity maps at 3 months
A 2-sample independent t-test will be employed to analyze the functional connectivity maps using SPM 12. Statistical maps will be computed to identify changes in striatum-seeded functional connectivity for between-group comparisons. The age will be regressed out as a covariate of non-interest. Significance will be threshold at the uncorrected voxel level p=0.001, followed by the FWE- corrected cluster level p=0.05.
Measured: Week 0, Week 12
Change from baseline homeostasis model assessment-estimated insulin resistance (HOMA-IR) index at several timepoints within 3 months
The homeostasis model assessment-estimated insulin resistance (HOMA-IR) index is calculated as the product of the fasting plasma insulin level (uIn/ml) and the fasting plasma glucose level (mg/dl), divided by 405. Insulin resistance is defined as HOMA-IR ≥2.5.
Measured: Week 0, Week 4, Week 8, Week 12
Change from baseline body mass index (BMI) at several timepoints within 3 months
Body weight (to the nearest 0.1 kg), body height (to the nearest 0.1 cm) will be measured and BMI (kg/m2) will be calculated accordingly.
Measured: Week 0, Week 4, Week 8, Week 12
Change from baseline waist and hip circumference at several timepoints within 3 months
Waist and hip circumference (to the nearest 0.1 cm) will be measured.
Measured: Week 0, Week 4, Week 8, Week 12
Change from baseline fasting serum leptin level at several timepoints within 3 months
Measured using ELISA method (Linco Research, USA). The limit of detection was 0.5 ng/mL, and the intra- and interassay coefficients of variation were 7% and 9%, respectively.
Measured: Week 0, Week 4, Week 8, Week 12
Change from baseline fasting serum lipid level at several timepoints within 3 months
Fasting total cholesterol, high density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL) and triglyceride (TG) concentrations will be measured.
Measured: Week 0, Week 4, Week 8, Week 12
Change from baseline immunological markers at several timepoints within 3 months
The fasting plasma CRP level will be assessed using an high-sensitivity CRP ELISA kit (Bender MedSystems, USA), for which the limit of detection was 3 pg/mL and the intra- and inter-assay coefficients of variation were 6.9% and 13.1%, respectively. The other immunological parameters to be analyzed include TNF-α, TGF-β1, IL-1, IL-8 and IL-10.
Measured: Week 0, Week 2, Week 3, Week 4, Week 8, Week 12
Change from baseline neurocognitive performance at 3 months
Neurocognitive performance will be assessed using Continuous Performance Test (CPT), Finger-Tapping Test (FTT) and Wisconsin Card-Sorting Test (WCST).
Measured: Week 0, Week 12
Change from baseline social cognitive function at 3 months
Mayer-Salovey-Caruso emotional Intelligent Test (MSCEIT): four branches: perceiving emotion (consisting of two tasks: face and picture tasks), facilitating emotion, understanding emotion, and managing emotion (Mayer, Salovey, Caruso, \& Sitarenios, 2003). The results will be scaled to a standard score based on the weight from the representative adult population (regarding age, gender, and ethnicity) in an extremely large sample of people (5,000). The reliability and validity of MSCEIT V2.0 have been proved before.
Measured: Week 0, Week 12
Change from baseline autonomic nervous system performance at several timepoints within 3 months
Cardiac autonomic function will be calculated by the geometric method, which is based on short-term measurements of the interbeat interval (IBI) [82]. Power spectral density analysis of HRV will be performed by fast Fourier transformation [83].
Measured: Week 0, Week 4, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start26 Aug 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
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.
- More trials run by National Cheng-Kung University 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117983
- Sponsor's protocol ID
- A-BR-110-005
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2021
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation Normalizes Dopaminergic Transmission in the Frontostriatal Circuit to Alleviate Depression With Metabolic Disorders.
- ClinicalTrials.gov ID
- NCT05117983
- Acronym / sponsor ID
- A-BR-110-005
- Conditions
- Depression
- Keywords
- Depression, Dopamine (DA), Frontostriatal (FS) circuit, Metabolic disorder, Repetitive transcranial magnetic stimulation (rTMS)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, Ministry of Health and Welfare, Taiwan
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Nov 2021 (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.
Depression and metabolic disorder (MetD) are two of the most common and debilitating disorders worldwide, occurring with significant rates of comorbidity. This is a major clinical challenge as the outcomes of both conditions are worsened. Studies have uncovered that depression and metabolic disorder are associated with chronic, low-grade inflammation. In brain circuit level, patients with depression are characterized with aberrant frontostriatal (FS) circuit connectivity and reduced activity level that also associated with metabolic comorbidity. In neurotransmitter level, the dopaminergic pathway, that could be feedback regulated by immune and metabolic factors, has long been known to involve in emotional and metabolic homeostasis. More importantly, this dopamine (DA) input is critical to shaping the FS circuit-level dynamic connectivity and plasticity. Therefore, this study hypothesizes that inflammatory and metabolic dysregulations on DA transmission link to the aberrant FS function that cause mood and metabolic syndromes. To clarify the underlying mechanisms, 90 patients who meet the DSM-5 diagnostic criteria of major depressive episode in either major depressive disorder or bipolar disorder are planned to be recruit. FS functional connectivity and activation, before and after receiving 10 Hz repetitive transcranial magnetic stimulation (rTMS) to left dorsolateral prefrontal cortex will be measured. Then systemically analyze participants' clinical symptomology, neurocognitive function, inflammation and metabolic status. Possible correlations between indices, the effects of rTMS and differences between groups will be tested. Results could provide a chance for further understanding the pathophysiology of depression with MetD and comparing between unipolar and bipolar depression, and developing brain circuit based non-invasive brain stimulation personalized treatment for depression with MetD to achieve a better outcome.
Detailed description
Depression and metabolic disorder (MetD) are two of the most common and debilitating disorders worldwide, occurring with significant rates of comorbidity. This is a major clinical challenge as the outcomes of both conditions are worsened. Studies have uncovered that depression and metabolic disorder are associated with chronic, low-grade inflammation. In brain circuit level, patients with depression are characterized with aberrant frontostriatal (FS) circuit connectivity and reduced activity level that also associated with metabolic comorbidity. BD patients also showed functional anomalies in the VS and FS circuits with reduced neural flexibility of hedonic signaling in response to stress. The dysfunctional FS circuits also link to the metabolic comorbidities in patients with mood disorders. Regarding metabolic control, the FS functional connectivity changes affect food craving. And the altered reciprocal loop from the medial prefrontal cortex could regulate eating behavior and metabolic disturbance. In neurotransmitter level, the dopaminergic pathway, that could be feedback regulated by immune and metabolic factors, has long been known to involve in emotional and metabolic homeostasis. More importantly, this dopamine (DA) input is critical to shaping the FS circuit-level dynamic connectivity and plasticity. Disruptions in the dopamine (DA) system have been observed in psychiatric disorders. MDD might involve DA reductions that could result from either diminished DA release from presynaptic neurons or impaired signal transduction, either due to changes in receptor number or function and/or altered intracellular signal processing. Therefore this study hypothesizes that inflammatory and metabolic dysregulations on DA transmission link to the aberrant FS function that cause depression and MetD. To clarify the underlying mechanisms, unipolar and bipolar depression patients will be enrolled to measure the FS functional connectivity and activation, before and after receiving 10 Hz repetitive transcranial magnetic stimulation (rTMS) to left dorsolateral prefrontal cortex. Then systemically analyze participants' clinical symptomology, neurocognitive function, inflammation and metabolic status. Possible correlations between indices, the effects of rTMS and the possible differences between unipolar and bipolar depression patients will be tested. Results could provide a chance for further understanding the pathophysiology and better treatment of depression with MetD, finding biomarkers for subgrouping depression between unipolar depression and bipolar depression, predicting outcomes to brain circuit based personalized rTMS treatment for depression with MetD.
The specific aims of the project are:
Aim 1: To find the biological homogeneousness among depression with MetD by investigate the associations between (1) FS circuit connectivity and clinical (mood and metabolic) symptoms, and (2) FS circuit activation and clinical (mood and metabolic) symptoms in both unipolar and bipolar depressed individuals.
Aim 2: To confirm the role of FS in depression with MetD by applying rTMS to test its effects on (1) clinical symptoms, (2) FS circuit activation, (3) FS circuit connectivity and (4) find predictors for the rTMS treatment response.
Aim 3: To study the bidirectional inflammatory and metabolic feedback regulations of the DA transmission in FS circuit in depression with MetD by investigate the associations between (1) FS circuit activation, and (2) FS circuit connectivity and systemic inflammatory/ metabolic regulators both before and after rTMS treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDD patient with HRSD score of at least 18 | Active comparator | Device: Repetitive transcranial magnetic stimulation (rTMS)MDD patients who meet the DSM-5 diagnostic criteria of MDD and their current episode show a Hamilton Rating Scale for Depression (HRSD) score of at least 18 |
| BD patient with HRSD score of at least 18 | Active comparator | Device: Repetitive transcranial magnetic stimulation (rTMS)BD patients who meet the DSM-5 diagnostic criteria of BD and their current depression episode show a Hamilton Rating Scale for Depression (HRSD) score of at least 18 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (1)Signed informed consent by patient or legal representative;
- (2) male or female patient aged ≧20 and ≦70 years;
- (3) a diagnosis of MDD or BD according to DSM criteria made by a specialist in psychiatry;
- (4) a total score of at least 18 in the Hamilton Rating Scale for Depression (HDRS) at the screening stage;
- (5) patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
Key exclusion criteria (12 listed)
- (1) women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study;
- (2) females who are pregnant or breast-feeding;
- (3) other major DSM 5 diagnoses other than mood disorders, except for tobacco use disorder and anxiety disorder;
- (4) current evidence of an uncontrolled and/or clinically significant medical condition, e.g. patients with extensive area of ischemic bruise, multiple sclerosis, cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation;
- (5) history of seizure or epilepsy;
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS)Also: AntidepressantsReal-time MRI-guided neuronavigation with a Visor neuronavigation system (ANT Neuro, Enschede, Netherlands) will be used for coil positioning. Left dorsolateral prefrontal cortex target is located in each participant. | Device | BD patient with HRSD score of at least 18, MDD patient with HRSD score of at least 18 |
Primary outcome
Change from baseline mood symptom severity at several timepoints over 3 months
Time frame: Week 0, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12.
Evaluation for disease severity by using the Hamilton Rating Scale for Depression (HAM-D) by trained senior psychiatrists. The same rater administers the scale for each patient.
Iowa gambling task (IGT) with functional MR imaging
Time frame: Week 0
The subject will be asked to turn a card from 4-decks voluntarily, and maximize gains and minimize losses during the game.
Change from baseline functional connectivity maps at 3 months
Time frame: Week 0, Week 12
A 2-sample independent t-test will be employed to analyze the functional connectivity maps using SPM 12. Statistical maps will be computed to identify changes in striatum-seeded functional connectivity for between-group comparisons. The age will be regressed out as a covariate of non-interest. Significance will be threshold at the uncorrected voxel level p=0.001, followed by the FWE- corrected cluster level p=0.05.
Change from baseline homeostasis model assessment-estimated insulin resistance (HOMA-IR) index at several timepoints within 3 months
Time frame: Week 0, Week 4, Week 8, Week 12
The homeostasis model assessment-estimated insulin resistance (HOMA-IR) index is calculated as the product of the fasting plasma insulin level (uIn/ml) and the fasting plasma glucose level (mg/dl), divided by 405. Insulin resistance is defined as HOMA-IR ≥2.5.
Change from baseline body mass index (BMI) at several timepoints within 3 months
Time frame: Week 0, Week 4, Week 8, Week 12
Body weight (to the nearest 0.1 kg), body height (to the nearest 0.1 cm) will be measured and BMI (kg/m2) will be calculated accordingly.
Change from baseline waist and hip circumference at several timepoints within 3 months
Time frame: Week 0, Week 4, Week 8, Week 12
Waist and hip circumference (to the nearest 0.1 cm) will be measured.
Change from baseline fasting serum leptin level at several timepoints within 3 months
Time frame: Week 0, Week 4, Week 8, Week 12
Measured using ELISA method (Linco Research, USA). The limit of detection was 0.5 ng/mL, and the intra- and interassay coefficients of variation were 7% and 9%, respectively.
Change from baseline fasting serum lipid level at several timepoints within 3 months
Time frame: Week 0, Week 4, Week 8, Week 12
Fasting total cholesterol, high density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL) and triglyceride (TG) concentrations will be measured.
Change from baseline immunological markers at several timepoints within 3 months
Time frame: Week 0, Week 2, Week 3, Week 4, Week 8, Week 12
The fasting plasma CRP level will be assessed using an high-sensitivity CRP ELISA kit (Bender MedSystems, USA), for which the limit of detection was 3 pg/mL and the intra- and inter-assay coefficients of variation were 6.9% and 13.1%, respectively. The other immunological parameters to be analyzed include TNF-α, TGF-β1, IL-1, IL-8 and IL-10.
Change from baseline neurocognitive performance at 3 months
Time frame: Week 0, Week 12
Neurocognitive performance will be assessed using Continuous Performance Test (CPT), Finger-Tapping Test (FTT) and Wisconsin Card-Sorting Test (WCST).
Change from baseline social cognitive function at 3 months
Time frame: Week 0, Week 12
Mayer-Salovey-Caruso emotional Intelligent Test (MSCEIT): four branches: perceiving emotion (consisting of two tasks: face and picture tasks), facilitating emotion, understanding emotion, and managing emotion (Mayer, Salovey, Caruso, \& Sitarenios, 2003). The results will be scaled to a standard score based on the weight from the representative adult population (regarding age, gender, and ethnicity) in an extremely large sample of people (5,000). The reliability and validity of MSCEIT V2.0 have been proved before.
Change from baseline autonomic nervous system performance at several timepoints within 3 months
Time frame: Week 0, Week 4, Week 12
Cardiac autonomic function will be calculated by the geometric method, which is based on short-term measurements of the interbeat interval (IBI) [82]. Power spectral density analysis of HRV will be performed by fast Fourier transformation [83].
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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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 Repetitive transcranial magnetic stimulation (rTMS) in people with Depression, run by National Cheng-Kung University 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 from baseline mood symptom severity at several timepoints over 3 months (time frame: Week 0, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12.). The study lists 12 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 20 Aug 2026.