Depressive Disorder, MajorNCT05212636
Using Repetitive Transcranial Magnetic Stimulation to Study the Role of Frontostriatal Circuit in Major Depressive Disorder
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Depressive Disorder, Major, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Major depressive disorder (MDD) is a common, severe, and often life-threatening illness that involves the body, mood, and thoughts. The natural course of MDD tends to worsen without treatment, while people with MDD can lead healthy and productive lives when the illness is effectively treated. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Depressive Disorder, Major
- 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
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 31 Oct 2021
- 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
- meet the DSM-5 diagnostic criteria and their current episode show a 17-item Hamilton Rating Scale for Depression (HRSD-17) score of at least 18
- show no clinical response to an adequate dose of an antidepressant
- could not tolerate at least two antidepressants in the current episode will be enrolled consecutively by trained psychiatrists
- Patients should receive a stable antidepressant regimen for at least 4 weeks before screening and continue during treatment
Who cannot join
- had DSM-5 diagnosis for substance abuse within the past three months
- had taken monoamine oxidase inhibitors
- had an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
- had a surgical condition or a major physical illness
- underwent course of electroconvulsive therapy (ECT) within the last three months
- the presence of a cardiac pacemaker, intracranial implant, or metal in the cranium
- taking any anticonvulsant or if more than three adequate antidepressant trials had failed (determined by antidepressant treatment history form).
Trial locations and contacts
1 site in 1 country.
About this study
Major depressive disorder (MDD) is a common, severe, and often life-threatening illness that involves the body, mood, and thoughts. The natural course of MDD tends to worsen without treatment, while people with MDD can lead healthy and productive lives when the illness is effectively treated. Up to 50% of the patients show no response to current available antidepressants.Two major non-invasive brain stimulation (NIBS) tools have been applied for the treatment of psychiatric diseases so far, transcranial magnetic and direct current stimulation (TMS, tDCS). TMS induces a strong magnetic field (magnetic pulses) through the skull into the brain, which generates electrical currents in brain tissue and induces neuronal firing, leading to after-effects, i.e. neuroplasticity, eventually. Neuronal effects of rTMS has been proven to last beyond the actual time of stimulation, enabling altered brain activity for an extended period of time. Adding on rTMS treatment could even give a chance to treat the physical comorbidities and enhance cognitive function in MDD. Nevertheless, underlying neurobiological mechanism of rTMS treatment remains unclear. Reports showed chronic psychosocial stressors are associated with altered frontal-striatal circuitry activation and connectivity. Indeed, aberrant fronto-striatal connectivity and reduced sustain fronto-striatal activation were noticed in MDD patients. However, the specific correlations between fronto-striatal connectivity changes and rTMS treatment outcomes in MDD remain unclear. In this study fMRI will be used to measure the possible correlations between the fronto-striatal circuit activation / connectivity with (1) mood symptoms presentations, (2) neurocognitive measurements, (3) HPA and ANS activities, and (4) immune and metabolic status (cytokines, adipokines and insulin levels) in patients with MDD. Then the possible changes in fronto-striatal FC over a four-week treatment course with 10 Hz rTMS stimulation to left dorsolateral prefrontal cortex will be measured. The FC changes will be tested to find out whether correlate with treatment outcomes, HPA and ANS activity; and immune/metabolic indices changes.
We hypothesize that rTMS as an add-on therapy would change the fronto-striatal FC that correlated with mood symptom improvement, neurocognitive measurements, HPA and ANS activity, inflammatory and metabolic homeostasis in patients with MDD.
Read the detailed description
BACKGROUNDＡND SIGNIFICANCE:
- The scale of the global impact of MDD is substantial, with mental illness constituting an estimated 7.4% of the world's measurable burden of disease. With a period of sustained disruption of mood, patients with MDD have the symptoms of distortions in perception and somatic functioning, and impairment in social functioning. Among the possible comorbidities, epidemiologic evidences have indicated increased risk of metabolic disturbances in MDD patients. The metabolic disturbances are correlated with higher morbidity and mortality in patients with MDD. Comorbid diabetes and MDD are a major clinical challenge as the outcomes of both conditions are worsened by the other.
- Although there are several types of antidepressant medications used to treat depressive disorders, up to 50% of the patients do not show response to antidepressants treatment. Importantly, increased inflammasome activation, cognitive impairment, and insulin resistance follow the non-remitting and recurrence in treating MDD, and might further dampen antidepressant treatment response. Moreover, the systemic effect of antidepressants treatment has linked to increased risk of metabolic disturbance. Recently, the development of non-invasive brain stimulation (NIBS) has provided alternative therapeutic options for psychiatric disorders. Two major NIBS tools have been applied for the treatment of psychiatric diseases so far, transcranial magnetic and direct current stimulation (TMS, tDCS). TMS includes induction of a strong magnetic field (magnetic pulses) through the skull into the brain. The magnetic pulses generate electrical currents in brain tissue and consequently induce neuronal firing. Repetitive TMS (rTMS) induces after-effects of the intervention, i.e. neuroplasticity. In general, low frequency (<1 Hz) rTMS reduces neuronal activity and cortical excitability, while higher frequency (>5 Hz) rTMS results in excitability enhancement. Neuronal effects of rTMS been proven to last beyond the actual time of stimulation, enabling altered brain activity for an extended period of time. The rTMS has emerged as a promising alternative strategy for treatment-resistant depression; however, the underlying neurobiological mechanisms are still not fully understood. In addition, adding on rTMS treatment could give a chance to treating the physical comorbidities and enhance cognitive function in MDD. The incorporation of biological assessments into future rTMS clinical studies will help in this regard.
- The frontal-striatal circuits mediate broadly dissociable cognitive and behavioural processes through limbic (ventromedial prefrontal regions, ventral striatum - VS, ventral tegmental area - VTA), motor (supplementary motor areas - SMAs, putamen, substantia nigra) and cognitive (lateral prefrontal and caudate) functional connectivity (FC). Reports had showed chronic psychosocial stressors are associated with altered frontal-striatal circuitry activation and connectivity. Structure and functional abnormalities of the striatum and frontal cortex have been reported consistently in studies in mood disorders. In MDD, patients are characterized by aberrant fronto-striatal connectivity and reduced sustain fronto-striatal activation. The MDD related executive dysfunction also showed clinical presentations and neuroimaging findings consistent with frontal-striatal circuitry abnormalities. Within the circuit, striatum is associated with reward and motor processing systems and receives emotion-related information and motivation from the frontal lobe, anterior cingulate cortex, and amygdala. The high incidence of depressive symptomatology following left frontal and basal ganglia lesions also implicate their roles in MDD. The dysfunctional fronto-striatal circuits also link to the metabolic comorbidities and cognitive deficits, that involved executive functioning, attention, processing speed, and working memory in patients with mood disorders. Regarding metabolic control, the fronto-striatal functional connectivity changes affect food craving. And the altered reciprocal loop from the medial prefrontal cortex could promote overeating and metabolic disturbance. Moreover, animal and clinical studies had suggested that striatal dopamine signaling plays a role in systemic glucose regulation. On the opposite, brain circuitry connectivity could be enhanced by either glucose loading or insulin challenge. Moreover, insulin resistance related aberrant functional circuitry has been demonstrated in patients with type 2 diabetes. Individuals with insulin resistance also showed aberrant fronto-striatal connectivity with failure to shift from reward toward cognitive control circuit.
- Changes in the ability to sustain fronto-striatal connectivity during the regulation of positive affect are associated with gains in positive affect through anti-depressants treatment. Duloxetine has been noted to modulate the FC between striatum and dorsolateral prefrontal cortex while showing symptomatic improvement. Moreover, the fronto-striatal connectivity attenuation among reward-processing regions could predict response to psychotherapy in MDD. Therefore, the degree of connectivity within the fronto-striatal circuit has been considered as a predictive biomarker of remission in treating MDD. Changes in FC might also relate to outcome of rTMS treatment of MDD. The FC variations represent the mechanism of action of rTMS and explain the individual difference in treatment outcome. However, the specific correlations between fronto-striatal connectivity changes and rTMS treatment outcomes in MDD remain unclear.
By using fMRI, in this project we will first measure the possible correlations between the fronto-striatal circuit activation/connectivity with (1) mood symptoms presentations, (2) neurocognitive measurements, (3) HPA and ANS activities, and (4) immune and metabolic status (cytokines, adipokines and insulin levels) in patients with MDD. Then we will measure the possible changes in fronto-striatal FC over a four-week treatment course with 10 Hz rTMS stimulation to left dorsolateral prefrontal cortex. We will test if the FC changes correlate with treatment outcomes, HPA and ANS activity; and immune/metabolic indices changes.
HYPOTHESIS:
We hypothesize that rTMS as an add-on therapy would change the fronto-striatal FC that correlated with mood symptom improvement, neurocognitive measurements, HPA and ANS activity, inflammatory and metabolic homeostasis in patients with MDD.
- Conditions
- Depressive Disorder, Major
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Repetitive Transcranial Magnetic Stimulation (rTMS), Major Depressive Disorder (MDD)
- Medical subject headings
- Depressive Disorder, Major
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
A total of 12 sessions of rTMS (5 sessions per week for 2 weeks, follow by 1 session per week for next 2 weeks) .
| Study group | Role | What they receive |
|---|---|---|
| MDD patient with HRSD score of at least 18 | Experimental | MDD patients who meet the DSM-5 diagnostic criteria of MDD and their current episode show a 17-Item 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 Numerous Timepoints within 3 Months Period
Evaluation for disease severity by using the 17-item Hamilton Rating Scale for Depression (HAM-D) by trained senior psychiatrists. The same rater administers the scale for each patient. Higher scores represent worse mood symptoms.
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 homeostasis model assessment-estimated insulin resistance (HOMA-IR) index at Numerous 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 Waist and Hip Circumference at Numerous Timepoints within 3 Months
Waist and hip circumference (to the nearest 0.1 cm)
Measured: Week 0, Week 4, Week 8, Week 12
Change from Baseline Fasting Serum Leptin Level at Numerous Timepoints within 3 Months
Measured using ELISA method (Linco Research, USA)
Measured: Week 0, Week 4, Week 8, Week 12
Change from Baseline Fasting Serum Lipid Level at Numerous 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 Numerous Timepoints within 3 Months
The fasting plasma CRP level will be assessed using an high-sensitivity CRP ELISA kit (Bender MedSystems, USA).
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Aug 2020
- Primary completion28 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Po-See, Chen, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212636
- Sponsor's protocol ID
- B-BR-108-092
- Status last verified
- Jan 2022
- First submitted
- 7 Oct 2021
- Last updated
- 28 Jan 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Repetitive Transcranial Magnetic Stimulation to Study the Role of Frontostriatal Circuit in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05212636
- Acronym / sponsor ID
- B-BR-108-092
- Conditions
- Depressive Disorder, Major
- Keywords
- Repetitive Transcranial Magnetic Stimulation (rTMS), Major Depressive Disorder (MDD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 28 Jan 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, severe, and often life-threatening illness that involves the body, mood, and thoughts. The natural course of MDD tends to worsen without treatment, while people with MDD can lead healthy and productive lives when the illness is effectively treated. Up to 50% of the patients show no response to current available antidepressants.Two major non-invasive brain stimulation (NIBS) tools have been applied for the treatment of psychiatric diseases so far, transcranial magnetic and direct current stimulation (TMS, tDCS). TMS induces a strong magnetic field (magnetic pulses) through the skull into the brain, which generates electrical currents in brain tissue and induces neuronal firing, leading to after-effects, i.e. neuroplasticity, eventually. Neuronal effects of rTMS has been proven to last beyond the actual time of stimulation, enabling altered brain activity for an extended period of time. Adding on rTMS treatment could even give a chance to treat the physical comorbidities and enhance cognitive function in MDD. Nevertheless, underlying neurobiological mechanism of rTMS treatment remains unclear. Reports showed chronic psychosocial stressors are associated with altered frontal-striatal circuitry activation and connectivity. Indeed, aberrant fronto-striatal connectivity and reduced sustain fronto-striatal activation were noticed in MDD patients. However, the specific correlations between fronto-striatal connectivity changes and rTMS treatment outcomes in MDD remain unclear. In this study fMRI will be used to measure the possible correlations between the fronto-striatal circuit activation / connectivity with (1) mood symptoms presentations, (2) neurocognitive measurements, (3) HPA and ANS activities, and (4) immune and metabolic status (cytokines, adipokines and insulin levels) in patients with MDD. Then the possible changes in fronto-striatal FC over a four-week treatment course with 10 Hz rTMS stimulation to left dorsolateral prefrontal cortex will be measured. The FC changes will be tested to find out whether correlate with treatment outcomes, HPA and ANS activity; and immune/metabolic indices changes.
We hypothesize that rTMS as an add-on therapy would change the fronto-striatal FC that correlated with mood symptom improvement, neurocognitive measurements, HPA and ANS activity, inflammatory and metabolic homeostasis in patients with MDD.
Detailed description
BACKGROUNDＡND SIGNIFICANCE:
- The scale of the global impact of MDD is substantial, with mental illness constituting an estimated 7.4% of the world's measurable burden of disease. With a period of sustained disruption of mood, patients with MDD have the symptoms of distortions in perception and somatic functioning, and impairment in social functioning. Among the possible comorbidities, epidemiologic evidences have indicated increased risk of metabolic disturbances in MDD patients. The metabolic disturbances are correlated with higher morbidity and mortality in patients with MDD. Comorbid diabetes and MDD are a major clinical challenge as the outcomes of both conditions are worsened by the other.
- Although there are several types of antidepressant medications used to treat depressive disorders, up to 50% of the patients do not show response to antidepressants treatment. Importantly, increased inflammasome activation, cognitive impairment, and insulin resistance follow the non-remitting and recurrence in treating MDD, and might further dampen antidepressant treatment response. Moreover, the systemic effect of antidepressants treatment has linked to increased risk of metabolic disturbance. Recently, the development of non-invasive brain stimulation (NIBS) has provided alternative therapeutic options for psychiatric disorders. Two major NIBS tools have been applied for the treatment of psychiatric diseases so far, transcranial magnetic and direct current stimulation (TMS, tDCS). TMS includes induction of a strong magnetic field (magnetic pulses) through the skull into the brain. The magnetic pulses generate electrical currents in brain tissue and consequently induce neuronal firing. Repetitive TMS (rTMS) induces after-effects of the intervention, i.e. neuroplasticity. In general, low frequency (<1 Hz) rTMS reduces neuronal activity and cortical excitability, while higher frequency (>5 Hz) rTMS results in excitability enhancement. Neuronal effects of rTMS been proven to last beyond the actual time of stimulation, enabling altered brain activity for an extended period of time. The rTMS has emerged as a promising alternative strategy for treatment-resistant depression; however, the underlying neurobiological mechanisms are still not fully understood. In addition, adding on rTMS treatment could give a chance to treating the physical comorbidities and enhance cognitive function in MDD. The incorporation of biological assessments into future rTMS clinical studies will help in this regard.
- The frontal-striatal circuits mediate broadly dissociable cognitive and behavioural processes through limbic (ventromedial prefrontal regions, ventral striatum - VS, ventral tegmental area - VTA), motor (supplementary motor areas - SMAs, putamen, substantia nigra) and cognitive (lateral prefrontal and caudate) functional connectivity (FC). Reports had showed chronic psychosocial stressors are associated with altered frontal-striatal circuitry activation and connectivity. Structure and functional abnormalities of the striatum and frontal cortex have been reported consistently in studies in mood disorders. In MDD, patients are characterized by aberrant fronto-striatal connectivity and reduced sustain fronto-striatal activation. The MDD related executive dysfunction also showed clinical presentations and neuroimaging findings consistent with frontal-striatal circuitry abnormalities. Within the circuit, striatum is associated with reward and motor processing systems and receives emotion-related information and motivation from the frontal lobe, anterior cingulate cortex, and amygdala. The high incidence of depressive symptomatology following left frontal and basal ganglia lesions also implicate their roles in MDD. The dysfunctional fronto-striatal circuits also link to the metabolic comorbidities and cognitive deficits, that involved executive functioning, attention, processing speed, and working memory in patients with mood disorders. Regarding metabolic control, the fronto-striatal functional connectivity changes affect food craving. And the altered reciprocal loop from the medial prefrontal cortex could promote overeating and metabolic disturbance. Moreover, animal and clinical studies had suggested that striatal dopamine signaling plays a role in systemic glucose regulation. On the opposite, brain circuitry connectivity could be enhanced by either glucose loading or insulin challenge. Moreover, insulin resistance related aberrant functional circuitry has been demonstrated in patients with type 2 diabetes. Individuals with insulin resistance also showed aberrant fronto-striatal connectivity with failure to shift from reward toward cognitive control circuit.
- Changes in the ability to sustain fronto-striatal connectivity during the regulation of positive affect are associated with gains in positive affect through anti-depressants treatment. Duloxetine has been noted to modulate the FC between striatum and dorsolateral prefrontal cortex while showing symptomatic improvement. Moreover, the fronto-striatal connectivity attenuation among reward-processing regions could predict response to psychotherapy in MDD. Therefore, the degree of connectivity within the fronto-striatal circuit has been considered as a predictive biomarker of remission in treating MDD. Changes in FC might also relate to outcome of rTMS treatment of MDD. The FC variations represent the mechanism of action of rTMS and explain the individual difference in treatment outcome. However, the specific correlations between fronto-striatal connectivity changes and rTMS treatment outcomes in MDD remain unclear.
By using fMRI, in this project we will first measure the possible correlations between the fronto-striatal circuit activation/connectivity with (1) mood symptoms presentations, (2) neurocognitive measurements, (3) HPA and ANS activities, and (4) immune and metabolic status (cytokines, adipokines and insulin levels) in patients with MDD. Then we will measure the possible changes in fronto-striatal FC over a four-week treatment course with 10 Hz rTMS stimulation to left dorsolateral prefrontal cortex. We will test if the FC changes correlate with treatment outcomes, HPA and ANS activity; and immune/metabolic indices changes.
HYPOTHESIS:
We hypothesize that rTMS as an add-on therapy would change the fronto-striatal FC that correlated with mood symptom improvement, neurocognitive measurements, HPA and ANS activity, inflammatory and metabolic homeostasis in patients with MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDD patient with HRSD score of at least 18 | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS)MDD patients who meet the DSM-5 diagnostic criteria of MDD and their current episode show a 17-Item 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 (4 listed)
- meet the DSM-5 diagnostic criteria and their current episode show a 17-item Hamilton Rating Scale for Depression (HRSD-17) score of at least 18
- show no clinical response to an adequate dose of an antidepressant
- could not tolerate at least two antidepressants in the current episode will be enrolled consecutively by trained psychiatrists
- Patients should receive a stable antidepressant regimen for at least 4 weeks before screening and continue during treatment
Key exclusion criteria (7 listed)
- had DSM-5 diagnosis for substance abuse within the past three months
- had taken monoamine oxidase inhibitors
- had an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
- had a surgical condition or a major physical illness
- underwent course of electroconvulsive therapy (ECT) within the last three months
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: AntidepressantsA total of 12 sessions of rTMS (5 sessions per week for 2 weeks, follow by 1 session per week for next 2 weeks) . | Device | MDD patient with HRSD score of at least 18 |
Primary outcome
Change from Baseline Mood Symptom Severity at Numerous Timepoints within 3 Months Period
Time frame: Week 0, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12.
Evaluation for disease severity by using the 17-item Hamilton Rating Scale for Depression (HAM-D) by trained senior psychiatrists. The same rater administers the scale for each patient. Higher scores represent worse mood symptoms.
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 homeostasis model assessment-estimated insulin resistance (HOMA-IR) index at Numerous 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 Waist and Hip Circumference at Numerous Timepoints within 3 Months
Time frame: Week 0, Week 4, Week 8, Week 12
Waist and hip circumference (to the nearest 0.1 cm)
Change from Baseline Fasting Serum Leptin Level at Numerous Timepoints within 3 Months
Time frame: Week 0, Week 4, Week 8, Week 12
Measured using ELISA method (Linco Research, USA)
Change from Baseline Fasting Serum Lipid Level at Numerous 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 Numerous 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).
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).
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 28 Jan 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.
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 Depressive Disorder, Major, 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 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: finished, as of the sponsor's last update on 28 Jan 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?
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?
Change from Baseline Mood Symptom Severity at Numerous Timepoints within 3 Months Period (time frame: Week 0, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12.). The study lists 8 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 28 Jan 2022.