DepressionNCT04720040
The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder
A study testing Mind STIM in people with Depression, run by Ybrain Inc. at 1 site in South Korea.
Trial summary
This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Mind STIM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Dec 2019to 15 Oct 2020
- 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
- Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features)
- Patients with a K-BDI-II score of 14 or more and 28 or less
- In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life.
Who cannot join
- Patients diagnosed with Axis I disorders other than major depressive disorder
- Patients diagnosed with other depressive disorders besides major depressive disorder
- Patients who have attempted suicide within 6 months of screening
- Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems
- Patients judged to have other reasons for prohibition of use of tDCS medical devices
- Patients currently taking antidepressants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using YMS-201B in Patients With Mild to Moderate Major Depressive Disorder To Evaluate Efficacy and Safety for the Effect of Improving Depressive Symptoms Open, Single-group, Multicenter Confirmatory Clinical Trial
This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.
Read the detailed description
Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5~7 times a week and they were evaluated every 2weeks through questionnaires.
- Conditions
- Depression
- Being tested
- Mind STIM
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind STIMDevice
transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
| Study group | Role | What they receive |
|---|---|---|
| YMS-201B | Experimental | transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 6 weeks (total of 30~42 applications) Receives: Device: Mind STIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Korean-Beck Depression Inventory-II
Average change of K-BDI-II at 6 weeks after treatment compare to the base respectively. This scale contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.The lower the total score, the better the symptoms.
Measured: At 6 weeks after treatment.
Secondary outcomes (2)
Korean-Beck Anxiety Depression Inventory
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.
Measured: Weeks 0, 2, 4, and 6
Hamilton Rating Scale for Depression
The HRSD has been criticized for use in clinical practice as it places more emphasis on insomnia than on feelings of hopelessness, self-destructive thoughts, suicidal cognitions and actions. This scale contained 17items and each item is scored on a 3 or 5point scale. The lower the total score, the better the symptoms.
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 posted22 Jan 2021
- Study start23 Dec 2019
- Primary completion31 Aug 2020
- Study completion15 Oct 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ybrain Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea, Inje University, Korea University, Seoul National University Bundang Hospital, Hallym University Medical Center, Soonchunhyang University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720040
- Sponsor's protocol ID
- YB_ST_SIT1902
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 22 Jan 2021
- 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 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using YMS-201B in Patients With Mild to Moderate Major Depressive Disorder To Evaluate Efficacy and Safety for the Effect of Improving Depressive Symptoms Open, Single-group, Multicenter Confirmatory Clinical Trial
- ClinicalTrials.gov ID
- NCT04720040
- Acronym / sponsor ID
- YB_ST_SIT1902
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ybrain Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea, Inje University, Korea University, Seoul National University Bundang Hospital, Hallym University Medical Center, Soonchunhyang University Hospital
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 22 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 evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.
Detailed description
Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5~7 times a week and they were evaluated every 2weeks through questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YMS-201B | Experimental | Device: Mind STIMtranscranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 6 weeks (total of 30~42 applications) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features)
- Patients with a K-BDI-II score of 14 or more and 28 or less
- In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life.
Key exclusion criteria (6 listed)
- Patients diagnosed with Axis I disorders other than major depressive disorder
- Patients diagnosed with other depressive disorders besides major depressive disorder
- Patients who have attempted suicide within 6 months of screening
- Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems
- Patients judged to have other reasons for prohibition of use of tDCS medical devices
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 |
|---|---|---|
| Mind STIMtranscranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) | Device | YMS-201B |
Primary outcome
Korean-Beck Depression Inventory-II
Time frame: At 6 weeks after treatment.
Average change of K-BDI-II at 6 weeks after treatment compare to the base respectively. This scale contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.The lower the total score, the better the symptoms.
2 secondary outcomes
Korean-Beck Anxiety Depression Inventory
Time frame: Weeks 0, 2, 4, and 6
Hamilton Rating Scale for Depression
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 22 Jan 2021.
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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 Mind STIM in people with Depression, run by Ybrain Inc. 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 3 inclusion and 6 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 22 Jan 2021. 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. 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?
Korean-Beck Depression Inventory-II (time frame: At 6 weeks after treatment.). 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 22 Jan 2021.