Major Depressive DisorderPhase 4NCT04543123
Effect of Self-administered tDCS in Patients With MDD
A Phase 4 study testing tDCS treatment and Antidepressant Drug(escitalopram) in people with Major Depressive Disorder, run by Jeong-Ho Chae at 1 site in South Korea.
Trial summary
In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- tDCS treatment and Antidepressant Drug(escitalopram)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2017to 2 May 2019
- Phase
- Phase 4
- 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
- Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features)
- Greater than 22 points of Montgomery-Asberg Depression Rating Scale
- Aged 19 to 65.
- Has provided informed consent
- Has received Escitalopram as a combined antidepressant during the study period
Who cannot join
- Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.)
- History of suicidal attempt in the last 6 months
- Diagnosed with bipolar or psychotic major depressive disorder
- Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
- Has hypersensitivity to Escitalopram ingredients
- A score of 5 or greater for the question #10 in MADRS
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- Diagnosed with closed angle glaucoma or has a history of glaucoma.
- History of participation in other clinical trials within 30days.
- A major and/or unstable medical or neurologic illness
- Currently taking substances pimozide
- Pregnant or has a positive pregnancy serum test.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 06591
About this study
Official title: Effect of Self-administered Transcranial Direct Stimulation in Patients With Major Depressive Disorder: A Prospective, Randomized, Single-blinded Clinical Trial
In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks.
Read the detailed description
Patients were randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients visited the hospital to get tDCS administrations 5 days a week for 2 weeks. They were evaluated every 2 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- tDCS treatment, Antidepressant Drug(escitalopram)
- 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.
tDCS treatmentDevice
Participants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week).
Antidepressant Drug(escitalopram)Drug
Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.
| Study group | Role | What they receive |
|---|---|---|
| sham tDCS treatment group | Sham comparator | the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes Receives: Device: tDCS treatment; Drug: Antidepressant Drug(escitalopram) |
| active tDCS treatment group | Experimental | 2mA of current was delivered during the 30 minutes of treatment Receives: Device: tDCS treatment; Drug: Antidepressant Drug(escitalopram) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HAM-D)
Hamilton Depression Scale was deployed by a trained psychiatrist at every visit.With a total of 17 questions, the overall score is rated from 0 to 34, and higher total scores indicate more severe depression symptoms
Measured: Change from Baseline Hamilton Depression Scale at 6 weeks
Secondary outcomes (3)
Beck Depression Inventory (BDI)
The self-rated scale of the Beck Depression Inventory (BDI) was completed by participants. With a total of 21 questions, the score is rated from 0 to 33, and higher total scores indicate more severe depression symptoms.
Measured: Weeks 0, 2, 4, and 6
Montgomery-Asberg Depression Rating Scale
Montgomery-Asberg Depression Rating Scale was deployed by a trained psychiatrist at every visit. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Measured: Weeks 0, 2, 4, and 6
Beck Anxiety Inventory
Beck Anxiety Inventory was deployed by a trained psychiatrist at every visit. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The overall score ranges from 0 to 63.
Measured: Weeks 0, 2, 4, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start16 Nov 2017
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeong-Ho Chae
- Sponsor type
- University, hospital or other
- Collaborators
- Ybrain Inc.
- Responsible party
- Sponsor-investigator, Jeong-Ho Chae, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543123
- Sponsor's protocol ID
- tDCS in MDD
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2020
- Last updated
- 9 Sep 2020
- 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 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-administered Transcranial Direct Stimulation in Patients With Major Depressive Disorder: A Prospective, Randomized, Single-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT04543123
- Acronym / sponsor ID
- tDCS in MDD
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Jeong-Ho ChaeUniversity, hospital or other
- Collaborators
- Ybrain Inc.
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 9 Sep 2020 (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.
In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks.
Detailed description
Patients were randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients visited the hospital to get tDCS administrations 5 days a week for 2 weeks. They were evaluated every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham tDCS treatment group | Sham comparator | Device: tDCS treatment, Drug: Antidepressant Drug(escitalopram)the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes |
| active tDCS treatment group | Experimental | Device: tDCS treatment, Drug: Antidepressant Drug(escitalopram)2mA of current was delivered during the 30 minutes of treatment |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features)
- Greater than 22 points of Montgomery-Asberg Depression Rating Scale
- Aged 19 to 65.
- Has provided informed consent
- Has received Escitalopram as a combined antidepressant during the study period
Key exclusion criteria (11 listed)
- Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.)
- History of suicidal attempt in the last 6 months
- Diagnosed with bipolar or psychotic major depressive disorder
- Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
- Has hypersensitivity to Escitalopram ingredients
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 |
|---|---|---|
| tDCS treatmentParticipants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week). | Device | active tDCS treatment group, sham tDCS treatment group |
| Antidepressant Drug(escitalopram)Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment. | Drug | active tDCS treatment group, sham tDCS treatment group |
Primary outcome
Hamilton Depression Scale (HAM-D)
Time frame: Change from Baseline Hamilton Depression Scale at 6 weeks
Hamilton Depression Scale was deployed by a trained psychiatrist at every visit.With a total of 17 questions, the overall score is rated from 0 to 34, and higher total scores indicate more severe depression symptoms
3 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: Weeks 0, 2, 4, and 6
Montgomery-Asberg Depression Rating Scale
Time frame: Weeks 0, 2, 4, and 6
Beck Anxiety Inventory
Time frame: Weeks 0, 2, 4, and 6
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 9 Sep 2020.
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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 Phase 4 study testing tDCS treatment and Antidepressant Drug(escitalopram) in people with Major Depressive Disorder, run by Jeong-Ho Chae at 1 site 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 5 inclusion and 11 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 9 Sep 2020. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hamilton Depression Scale (HAM-D) (time frame: Change from Baseline Hamilton Depression Scale at 6 weeks). 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 9 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.