DepressionNCT07500064
Transcranial Direct Current Stimulation for Depression
A study testing transcranial direct current stimulation (tDCS) in people with Depression, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial summary
Background: Depression is a common mental disorder characterized by persistent low mood and anhedonia. Pharmacological and psychotherapeutic treatments demonstrate only moderate efficacy. Non-invasive brain stimulation techniques offer novel therapeutic approaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 31 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis meets the criteria for depression outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Age between 18 and 65 years.
- Education level exceeding 5 years, with no significant hearing or visual impairments.
- Voluntary signing of informed consent and ability to cooperate with general demographic data collection and neuropsychological scale testing.
Who cannot join
- Age under 18 or over 65.
- Patients with neurological disorders such as epilepsy or severe physical illnesses.
- Patients with comorbid neuropsychiatric disorders, such as schizophrenia or obsessive-compulsive disorder.
- Patients unable to undergo tDCS treatment for any reason, including presence of ferromagnetic metal in the head or implanted medical devices in the head/neck region.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Nanxue Duan, +86-18326962052, 791909941@qq.com
About this study
Official title: A Comparative Study of the Clinical Efficacy of Transcranial Direct Current Stimulation Targeting the DLPFC Versus DMPFC in the Treatment of Depression
Background:
Depression is a common mental disorder characterized by persistent low mood and anhedonia. Pharmacological and psychotherapeutic treatments demonstrate only moderate efficacy. Non-invasive brain stimulation techniques offer novel therapeutic approaches. Among these, transcranial direct current stimulation (tDCS) holds advantages due to its simplicity, low cost, and minimal side effects, exhibiting good efficacy and tolerability in depression treatment. The dorsolateral prefrontal cortex (DLPFC), a core region of the cognitive control network, serves as a traditional target for non-invasive brain stimulation in depression and plays a crucial role in positive affect (PA) processing. Conversely, the dorsomedial prefrontal cortex (DMPFC), a central region of the default mode network, participates in negative self-referential processing and negative affect (NA) regulation, demonstrating potential as a novel therapeutic target.
Read more
Objective:
Given the distinct roles of DLPFC and DMPFC in separate affective regulation networks, this study aims to investigate the differential effects of different tDCS targets on emotional regulation in patients with depression.
Design:
This study employed a randomized, double-blind, controlled design. Participants diagnosed with depression will be randomly assigned to receive either effective tDCS targeting the left DLPFC or effective tDCS targeting the DMPFC. Primary outcome measures focus on changes in clinical symptom assessments.
Read the detailed description
Background:
Depression is a common mental disorder characterized by persistent low mood and anhedonia. Pharmacological and psychotherapeutic treatments demonstrate only moderate efficacy. Non-invasive brain stimulation techniques offer novel therapeutic approaches. Among these, transcranial direct current stimulation (tDCS) holds advantages due to its simplicity, low cost, and minimal side effects, exhibiting good efficacy and tolerability in depression treatment. The dorsolateral prefrontal cortex (DLPFC), a core region of the cognitive control network, serves as a traditional target for non-invasive brain stimulation in depression and plays a crucial role in positive affect (PA) processing. Conversely, the dorsomedial prefrontal cortex (DMPFC), a central region of the default mode network, participates in negative self-referential processing and negative affect (NA) regulation, demonstrating potential as a novel therapeutic target.
Objective:
Given the distinct roles of DLPFC and DMPFC in different affective regulation networks, this study aims to investigate the differential effects of tDCS targeting these regions on emotional regulation in patients with depression.
Design:
This study employed a randomized, double-blind, controlled design. Inpatients with depression were recruited from the Department of Psychology and Sleep Medicine at the Second Affiliated Hospital of Anhui Medical University. Participants were randomly assigned to receive either effective tDCS targeting the left DLPFC or effective tDCS targeting the DMPFC. Both groups will receive tDCS treatment twice daily for 5 consecutive days. Each session lasts 20 minutes at 2mA, with a minimum 4-hour interval between sessions. Before the start of tDCS treatment and after completion of all sessions, clinical psychologists conducted standardized assessments and collected EEG data from the patients. Assessments included tests of associative memory, the Self-Rating Depression Scale (SDS), the 17-item Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), 15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15), PHQ-15), the Insomnia Severity Index (ISI), the Positive and Negative Affect Scale (PANAS), and the Ruminative Responses Scale (RRS). Follow-up was conducted after one month, during which only the HAMD scale was assessed. Primary clinical outcomes included changes in HAMD scores at baseline, post-treatment, and 1-month follow-up; number of responders and remitters post-treatment (response defined as >50% reduction in HAMD score at endpoint; remission defined as HAMD score ≤7 at endpoint); improvement in PANAS scores post-treatment; correlation between HAMD improvement and PANAS improvement. Secondary outcomes included changes in residual scale scores post-treatment, changes in EEG signals in stimulated brain regions, and changes in functional connectivity across the entire brain.
- Conditions
- Depression
- Being tested
- transcranial direct current stimulation (tDCS)
- Keywords
- depression, transcranial direct current stimulation, dorsolateral prefrontal cortex, dorsomedial prefrontal cortex
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
Stimulation was delivered using a high-precision transcranial direct current stimulation (tDCS) device (Soterix Medical, Inc., New York, USA) via five small electrode pads (1 cm × 1 cm) arranged in a 4×1 ring configuration.
| Study group | Role | What they receive |
|---|---|---|
| DLPFC group | Active comparator | Participants will receive 10 sessions of transcranial direct current stimulation (tDCS) treatment over 5 days, with stimulation targeting the dorsolateral prefrontal cortex (DLPFC). Receives: Device: transcranial direct current stimulation (tDCS) |
| DMPFC group | Active comparator | Participants will receive 10 sessions of transcranial direct current stimulation (tDCS) treatment over 5 days, with stimulation targeting the dorsomedial prefrontal cortex (DMPFC). Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Depression Rating Scale (HAMD)
Improvement in HAMD scores following transcranial direct current stimulation (tDCS) treatment (The HAMD consists of 17 items, with a total score ranging from 0 to 53; a higher score indicates more severe depressive symptoms).
Measured: Baseline, immediately after all intervention, and follow-up after all intervention (1 month).
Positive and Negative Affect Schedule (PANAS)
The degree of improvement in PANAS scores following transcranial direct current stimulation (used to assess patients' positive and negative emotions; consisting of 20 items, with 10 items representing positive emotions; the total positive emotion score ranges from 0 to 50, with higher scores indicating greater vitality and enthusiasm; the other 10 items represent negative emotions, with the total negative emotion score ranging from 0 to 50; higher scores indicate stronger negative emotions).
Measured: Baseline and immediately after all intervention.
Secondary outcomes (6)
Self-Rating Depression Scale (SDS)
Improvement in SDS (SDS comprises 20 items with a total score range of 0-100; higher scores indicate more severe depressive symptoms) scores following transcranial direct current stimulation treatment.
Measured: Baseline and immediately after all intervention.
Hamilton Anxiety Rating Scale (HAMA)
Improvement in HAMA (HAMA comprises 14 items with a total score range of 0-56; higher scores indicate more severe anxiety symptoms) scores following transcranial direct current stimulation treatment.
Measured: Baseline and immediately after all intervention.
15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15)
Improvement in PHQ-15(comprising 15 items with a total score of 30; higher scores indicate more severe somatization symptoms) scores following transcranial direct current stimulation treatment.
Measured: Baseline and immediately after all intervention.
Insomnia Severity Index (ISI)
Improvement in ISI(comprising 7 items with a total score of 28; higher scores indicate more severe insomnia) scores following transcranial direct current stimulation treatment.
Measured: Baseline and immediately after all intervention.
Ruminative Responses Scale (RRS)
Improvement in RRS (comprising 22 items with a total score of 88; higher scores indicate more severe rumination tendencies) scores following transcranial direct current stimulation treatment.
Measured: Baseline and immediately after all intervention.
EEG measurements
Changes in EEG signal metrics in the stimulated target brain regions and in functional connectivity with the entire brain.
Measured: Baseline and immediately after all intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start30 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 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.
- 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
- Model description
- Stimulation was delivered using a high-precision transcranial direct current stimulation (tDCS) device (Soterix Medical, Inc., New York, USA) via five small electrode pads (1 cm × 1 cm) arranged in a 4×1 ring configuration. Following the international 10/20 EEG system: For the dorsolateral prefrontal cortex (DLPFC) group, the anode centered at F3 received 100% of the 2 mA current, while the cathode received 25% of the current via four peripheral electrodes at Fp1, F7, C3, and Fz. For the dorsomedial prefrontal cortex (DMPFC) group, the anode centered at Fz received 100% of the 2 mA current, while the cathode centered at Fz received 25% of the current via four peripheral electrodes at Fpz, F3, Cz, and F4. Participating patients with depression were randomly assigned to receive either active tDCS targeting the left DLPFC or active tDCS targeting the DMPFC. Both groups received tDCS treatment twice daily for 5 days, with each session lasting 20 minutes at 2 mA.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanghua Tian, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500064
- Sponsor's protocol ID
- AHMU-DLPFC/DMPFC-DEPRESSION
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Clinical Efficacy of Transcranial Direct Current Stimulation Targeting the DLPFC Versus DMPFC in the Treatment of Depression
- ClinicalTrials.gov ID
- NCT07500064
- Acronym / sponsor ID
- AHMU-DLPFC/DMPFC-DEPRESSION
- Conditions
- Depression
- Keywords
- depression, transcranial direct current stimulation, dorsolateral prefrontal cortex, dorsomedial prefrontal cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Mar 2026 (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.
Background:
Depression is a common mental disorder characterized by persistent low mood and anhedonia. Pharmacological and psychotherapeutic treatments demonstrate only moderate efficacy. Non-invasive brain stimulation techniques offer novel therapeutic approaches. Among these, transcranial direct current stimulation (tDCS) holds advantages due to its simplicity, low cost, and minimal side effects, exhibiting good efficacy and tolerability in depression treatment. The dorsolateral prefrontal cortex (DLPFC), a core region of the cognitive control network, serves as a traditional target for non-invasive brain stimulation in depression and plays a crucial role in positive affect (PA) processing. Conversely, the dorsomedial prefrontal cortex (DMPFC), a central region of the default mode network, participates in negative self-referential processing and negative affect (NA) regulation, demonstrating potential as a novel therapeutic target.
Objective:
Given the distinct roles of DLPFC and DMPFC in separate affective regulation networks, this study aims to investigate the differential effects of different tDCS targets on emotional regulation in patients with depression.
Design:
This study employed a randomized, double-blind, controlled design. Participants diagnosed with depression will be randomly assigned to receive either effective tDCS targeting the left DLPFC or effective tDCS targeting the DMPFC. Primary outcome measures focus on changes in clinical symptom assessments.
Detailed description
Background:
Depression is a common mental disorder characterized by persistent low mood and anhedonia. Pharmacological and psychotherapeutic treatments demonstrate only moderate efficacy. Non-invasive brain stimulation techniques offer novel therapeutic approaches. Among these, transcranial direct current stimulation (tDCS) holds advantages due to its simplicity, low cost, and minimal side effects, exhibiting good efficacy and tolerability in depression treatment. The dorsolateral prefrontal cortex (DLPFC), a core region of the cognitive control network, serves as a traditional target for non-invasive brain stimulation in depression and plays a crucial role in positive affect (PA) processing. Conversely, the dorsomedial prefrontal cortex (DMPFC), a central region of the default mode network, participates in negative self-referential processing and negative affect (NA) regulation, demonstrating potential as a novel therapeutic target.
Objective:
Given the distinct roles of DLPFC and DMPFC in different affective regulation networks, this study aims to investigate the differential effects of tDCS targeting these regions on emotional regulation in patients with depression.
Design:
This study employed a randomized, double-blind, controlled design. Inpatients with depression were recruited from the Department of Psychology and Sleep Medicine at the Second Affiliated Hospital of Anhui Medical University. Participants were randomly assigned to receive either effective tDCS targeting the left DLPFC or effective tDCS targeting the DMPFC. Both groups will receive tDCS treatment twice daily for 5 consecutive days. Each session lasts 20 minutes at 2mA, with a minimum 4-hour interval between sessions. Before the start of tDCS treatment and after completion of all sessions, clinical psychologists conducted standardized assessments and collected EEG data from the patients. Assessments included tests of associative memory, the Self-Rating Depression Scale (SDS), the 17-item Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), 15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15), PHQ-15), the Insomnia Severity Index (ISI), the Positive and Negative Affect Scale (PANAS), and the Ruminative Responses Scale (RRS). Follow-up was conducted after one month, during which only the HAMD scale was assessed. Primary clinical outcomes included changes in HAMD scores at baseline, post-treatment, and 1-month follow-up; number of responders and remitters post-treatment (response defined as >50% reduction in HAMD score at endpoint; remission defined as HAMD score ≤7 at endpoint); improvement in PANAS scores post-treatment; correlation between HAMD improvement and PANAS improvement. Secondary outcomes included changes in residual scale scores post-treatment, changes in EEG signals in stimulated brain regions, and changes in functional connectivity across the entire brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Stimulation was delivered using a high-precision transcranial direct current stimulation (tDCS) device (Soterix Medical, Inc., New York, USA) via five small electrode pads (1 cm × 1 cm) arranged in a 4×1 ring configuration. Following the international 10/20 EEG system: For the dorsolateral prefrontal cortex (DLPFC) group, the anode centered at F3 received 100% of the 2 mA current, while the cathode received 25% of the current via four peripheral electrodes at Fp1, F7, C3, and Fz. For the dorsomedial prefrontal cortex (DMPFC) group, the anode centered at Fz received 100% of the 2 mA current, while the cathode centered at Fz received 25% of the current via four peripheral electrodes at Fpz, F3, Cz, and F4. Participating patients with depression were randomly assigned to receive either active tDCS targeting the left DLPFC or active tDCS targeting the DMPFC. Both groups received tDCS treatment twice daily for 5 days, with each session lasting 20 minutes at 2 mA.
| Arm | Type | Receives |
|---|---|---|
| DLPFC group | Active comparator | Device: transcranial direct current stimulation (tDCS)Participants will receive 10 sessions of transcranial direct current stimulation (tDCS) treatment over 5 days, with stimulation targeting the dorsolateral prefrontal cortex (DLPFC). |
| DMPFC group | Active comparator | Device: transcranial direct current stimulation (tDCS)Participants will receive 10 sessions of transcranial direct current stimulation (tDCS) treatment over 5 days, with stimulation targeting the dorsomedial prefrontal cortex (DMPFC). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The diagnosis meets the criteria for depression outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Age between 18 and 65 years.
- Education level exceeding 5 years, with no significant hearing or visual impairments.
- Voluntary signing of informed consent and ability to cooperate with general demographic data collection and neuropsychological scale testing.
Key exclusion criteria (5 listed)
- Age under 18 or over 65.
- Patients with neurological disorders such as epilepsy or severe physical illnesses.
- Patients with comorbid neuropsychiatric disorders, such as schizophrenia or obsessive-compulsive disorder.
- Patients unable to undergo tDCS treatment for any reason, including presence of ferromagnetic metal in the head or implanted medical devices in the head/neck region.
- Pregnant or lactating women.
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 |
|---|---|---|
| transcranial direct current stimulation (tDCS)Stimulation was delivered using a high-precision transcranial direct current stimulation (tDCS) device (Soterix Medical, Inc., New York, USA) via five small electrode pads (1 cm × 1 cm) arranged in a 4×1 ring configuration. | Device | DLPFC group, DMPFC group |
Primary outcome
17-item Hamilton Depression Rating Scale (HAMD)
Time frame: Baseline, immediately after all intervention, and follow-up after all intervention (1 month).
Improvement in HAMD scores following transcranial direct current stimulation (tDCS) treatment (The HAMD consists of 17 items, with a total score ranging from 0 to 53; a higher score indicates more severe depressive symptoms).
Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline and immediately after all intervention.
The degree of improvement in PANAS scores following transcranial direct current stimulation (used to assess patients' positive and negative emotions; consisting of 20 items, with 10 items representing positive emotions; the total positive emotion score ranges from 0 to 50, with higher scores indicating greater vitality and enthusiasm; the other 10 items represent negative emotions, with the total negative emotion score ranging from 0 to 50; higher scores indicate stronger negative emotions).
6 secondary outcomes
Self-Rating Depression Scale (SDS)
Time frame: Baseline and immediately after all intervention.
Hamilton Anxiety Rating Scale (HAMA)
Time frame: Baseline and immediately after all intervention.
15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15)
Time frame: Baseline and immediately after all intervention.
Insomnia Severity Index (ISI)
Time frame: Baseline and immediately after all intervention.
Ruminative Responses Scale (RRS)
Time frame: Baseline and immediately after all intervention.
EEG measurements
Time frame: Baseline and immediately after all intervention.
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 19 May 2026.
- Individual participant dataSharing planned: No. There is no current plan to make individual participant data available to other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Depression, run by The Second Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 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 China. 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?
Contact Yanghua Tian (+86-13955188448, tianyh@ahmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17-item Hamilton Depression Rating Scale (HAMD) (time frame: Baseline, immediately after all intervention, and follow-up after all intervention (1 month).). 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 19 May 2026.