DepressionNCT04709952
Postmarketing Clinical Trial of tDCS to Evaluate Cognitive Ability in Depression Patients
A study testing Transcranial direct current stimulation_High real and Transcranial direct current stimulation_Low real in people with Depression, run by ji hyun baek, MD, Ph.D at 2 sites in South Korea.
Trial summary
This study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1mA), high real stimulation group (2mA) and treatment every day for 6 weeks (a total of 42 times). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Transcranial direct current stimulation_High real and Transcranial direct current stimulation_Low real
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 28 Jan 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of major depressive disorder
- CGI severity (severity of Illness) score of 3 or higher
- Patients receiving medication for depression at the time of study participation
- Those who can read and understand the subject's explanation and consent form and who can respond to questionnaires
Who cannot join
- History of clinically significant medical neurological disease or history of head injury
- In case of mental retardation or cognitive impairment enough to affect the writing of consent form or conducting research
- Severe suicidal risk or psychotic symptoms determined by the clinician
- In the case of a contraindication to the implementation of tDCS (when a metallic auxiliary tool is inserted in the head)
- Those who are judged to have problems with the attachment of EEG and DC stimulation electrodes due to deformities, inflammatory reactions, or other dermatological problems at the electrode attachment site
- Among female subjects who are likely to become pregnant, those who do not agree to contraception by a medically acceptable method for up to 24 weeks after application of the investigational medical device in this clinical trial
- Pregnant women
- Any other person who has reasons to judge that the investigator is unsuitable for participation in the clinical trial
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si
Woojae Myung, MD, PhD, +31)31-787-2720, smbhealer@gmail.com
- Recruiting
Samsung Medical Center
Seoul
Ji-Hyun Baek, M.D., Ph.D., +82 1093355988, jihyunbaek@skku.edu
About this study
Official title: A Clinical Trial Study on the Market to Establish the Safety and Efficacy of a Transcranial DC Stimulation Device in Patients With Depression
This study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1mA), high real stimulation group (2mA) and treatment every day for 6 weeks (a total of 42 times). As a primary outcome, the investigator analyze the improvement effect of working memory ability, and confirm whether the effects of anxiety and depression are improved by the secondary outcome, together with the quality of life evaluation.
Read the detailed description
During the clinical trial period, a total of 4 to 5 outpatient visits are made, and changes are evaluated through neuropsychological examination by visiting at 2, 4 and 6 weeks based on the baseline time point. In addition, in the case of patients who agree after 6 weeks of participation, an additional 6 weeks of high real stimulation is used to conduct an open extension study.
- Conditions
- Depression
- Being tested
- Transcranial direct current stimulation_High real, Transcranial direct current stimulation_Low real, Transcranial direct current stimulation_Sham
- 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_High realDevice
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in high real stimulation group (2mA).
Transcranial direct current stimulation_Low realDevice
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in Low real stimulation group (1mA).
Transcranial direct current stimulation_ShamDevice
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in sham stimulation group (0mA).
| Study group | Role | What they receive |
|---|---|---|
| High real stimulation group | Active comparator | 2mA tDCS stimulation daily (42 times) for 6 weeks Receives: Device: Transcranial direct current stimulation_High real |
| Low real stimulation group | Active comparator | 1mA tDCS stimulation daily (42 times) for 6 weeks Receives: Device: Transcranial direct current stimulation_Low real |
| Sham stimulation group | Sham comparator | sham stimulation daily (42 times) for 6 weeks Receives: Device: Transcranial direct current stimulation_Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory ability evaluation(N-Back tast)
N-back tasks are continuous-recognition measures that present stimulus sequences, such as letters or pictures; for each item in the sequence, people judge whether it matches the one presented n items ago. As the number of correct answers increases, it means improvement in cognitive function.
Measured: Change from Baseline Working memory ability evaluation at 6 weeks.
Secondary outcomes (2)
Hamilton Rating Scale
The patient is rated by a clinician on 17 items scored either on a 3-point or 5-point Likert-type scale. The lower the total score, the better the symptoms.
Measured: Change from Baseline Hamilton Rating Scale evaluation at 2,4,6 weeks
Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Upon the completion of the evaluation, the clinician compiles a total, composite score based upon the summation of each of the 14 individually rated items. This calculation will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity.The lower the total score, the better the symptoms.
Measured: Change from Baseline Hamilton Anxiety Rating Scale evaluation at 2,4,6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start28 Jan 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ji hyun baek, MD, Ph.D
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ji hyun baek, MD, Ph.D, Samsung Medical Center
- Investigators
- Ji-Hyun Baek, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709952
- Sponsor's protocol ID
- YB_ST_IIT2006
- Status last verified
- Sep 2021
- First submitted
- 12 Jan 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee CW, Park K, Ahn JE, Jang Y, Park YS, Yu H, Lee D, Ihm HK, Lee J, Kim J, Lee YI, Lim SE, Kwon SS, Park HY, Ha TH, Yoon IY, Myung W, Baek JH. Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial. Eur Psychiatry. 2025 Jan 15;68(1):e15. doi: 10.1192/j.eurpsy.2024.1811.
PubMed 39809704
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Study on the Market to Establish the Safety and Efficacy of a Transcranial DC Stimulation Device in Patients With Depression
- ClinicalTrials.gov ID
- NCT04709952
- Acronym / sponsor ID
- YB_ST_IIT2006
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- ji hyun baek, MD, Ph.DUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 14 Jan 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.
This study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1mA), high real stimulation group (2mA) and treatment every day for 6 weeks (a total of 42 times). As a primary outcome, the investigator analyze the improvement effect of working memory ability, and confirm whether the effects of anxiety and depression are improved by the secondary outcome, together with the quality of life evaluation.
Detailed description
During the clinical trial period, a total of 4 to 5 outpatient visits are made, and changes are evaluated through neuropsychological examination by visiting at 2, 4 and 6 weeks based on the baseline time point. In addition, in the case of patients who agree after 6 weeks of participation, an additional 6 weeks of high real stimulation is used to conduct an open extension study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High real stimulation group | Active comparator | Device: Transcranial direct current stimulation_High real2mA tDCS stimulation daily (42 times) for 6 weeks |
| Low real stimulation group | Active comparator | Device: Transcranial direct current stimulation_Low real1mA tDCS stimulation daily (42 times) for 6 weeks |
| Sham stimulation group | Sham comparator | Device: Transcranial direct current stimulation_Shamsham stimulation daily (42 times) for 6 weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of major depressive disorder
- CGI severity (severity of Illness) score of 3 or higher
- Patients receiving medication for depression at the time of study participation
- Those who can read and understand the subject's explanation and consent form and who can respond to questionnaires
Key exclusion criteria (8 listed)
- History of clinically significant medical neurological disease or history of head injury
- In case of mental retardation or cognitive impairment enough to affect the writing of consent form or conducting research
- Severe suicidal risk or psychotic symptoms determined by the clinician
- In the case of a contraindication to the implementation of tDCS (when a metallic auxiliary tool is inserted in the head)
- Those who are judged to have problems with the attachment of EEG and DC stimulation electrodes due to deformities, inflammatory reactions, or other dermatological problems at the electrode attachment site
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_High realTranscranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in high real stimulation group (2mA). | Device | High real stimulation group |
| Transcranial direct current stimulation_Low realTranscranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in Low real stimulation group (1mA). | Device | Low real stimulation group |
| Transcranial direct current stimulation_ShamTranscranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in sham stimulation group (0mA). | Device | Sham stimulation group |
Primary outcome
Working memory ability evaluation(N-Back tast)
Time frame: Change from Baseline Working memory ability evaluation at 6 weeks.
N-back tasks are continuous-recognition measures that present stimulus sequences, such as letters or pictures; for each item in the sequence, people judge whether it matches the one presented n items ago. As the number of correct answers increases, it means improvement in cognitive function.
2 secondary outcomes
Hamilton Rating Scale
Time frame: Change from Baseline Hamilton Rating Scale evaluation at 2,4,6 weeks
Hamilton Anxiety Rating Scale
Time frame: Change from Baseline Hamilton Anxiety Rating Scale evaluation at 2,4,6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 39809704Lee CW, Park K, Ahn JE, Jang Y, Park YS, Yu H, Lee D, Ihm HK, Lee J, Kim J, Lee YI, Lim SE, Kwon SS, Park HY, Ha TH, Yoon IY, Myung W, Baek JH. Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial. Eur Psychiatry. 2025 Jan 15;68(1):e15. doi: 10.1192/j.eurpsy.2024.1811.
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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.
Ji-Hyun Baek principal investigator
Samsung Medical Center
2 sites 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_High real and Transcranial direct current stimulation_Low real in people with Depression, run by ji hyun baek, MD, Ph.D at 2 sites in South Korea.
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 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-Hyun Baek (+82 2-2008-4388, jh1.baek@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working memory ability evaluation(N-Back tast) (time frame: Change from Baseline Working memory ability evaluation at 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04709952, which also lists 1 linked publication.
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 23 Sep 2021.