Major Depressive DisorderPhase 3NCT02657980
The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder
A Phase 3 study testing Yband(YDT-201N) in people with Major Depressive Disorder, run by Ybrain Inc. at 1 site in South Korea.
Trial summary
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment 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?
- Yband(YDT-201N)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Dec 2016
- Phase
- Phase 3
- 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
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 sertraline 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 that contain sertraline, mono amine oxidase inhibitor, or pimozide
- Pregnant or has a positive pregnancy serum test.
Trial locations and contacts
1 site in 1 country.
About this study
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Read the detailed description
Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week for 2 weeks. They will be evaluated every 2 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- Yband(YDT-201N), Sham-Yband(YDT-201N)
- Keywords
- Major Depressive Disorder, tDCS, MDD, transcranial Direct Current Stimulation
- 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.
Yband(YDT-201N)Device
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)
Sham-Yband(YDT-201N)Device
transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
| Study group | Role | What they receive |
|---|---|---|
| YBand(YDT-201N) | Experimental | transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications) Receives: Device: Yband(YDT-201N) |
| Sham-Yband(YDT-201N) | Sham comparator | sham-tDCS application 5 days a week for 2 weeks (total of 10 applications) Receives: Device: Sham-Yband(YDT-201N) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: from baseline to Week 6
Secondary outcomes (5)
Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
The percentage of subjects whose MADRS score decreases over 50% against the base in week 6 after treatment.
Measured: At 6 weeks after treatment.
Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
The percentage of subjects whose MADRS score is under 10 in week 6 after treatment.
Measured: At 6 weeks after treatment
Average change in results for 2, 4, 6 weeks after treatment as assessed by the clinician-rated Clinical Global Impression-Severity of Illness Scale (CGISI)
Average change of CGISI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.
Measured: At 2 weeks, 4 weeks and 6 weeks after treatment
Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II)
Average change of K-BDI-II at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.
Measured: At 2 weeks, 4 weeks and 6 weeks after treatment
Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI)
Average change of K-BAI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.
Measured: At 2 weeks, 4 weeks and 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionDec 2016
- Study completionDec 2016
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ybrain Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital, Gangnam Severance Hospital, Myongji Hospital, CHA University, National Health Insurance Service Ilsan Hospital, Ajou University, Hallym University Medical Center
- Responsible party
- Sponsor
- Investigators
- Seungwoo Lee, Study director, Ybrain Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657980
- Sponsor's protocol ID
- MUL003MDD
- Status last verified
- Jan 2017
- First submitted
- 22 Jun 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02657980
- Acronym / sponsor ID
- MUL003MDD
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, tDCS, MDD, transcranial Direct Current Stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ybrain Inc.Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital, Gangnam Severance Hospital, Myongji Hospital, CHA University, National Health Insurance Service Ilsan Hospital, Ajou University, Hallym University Medical Center
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Jan 2016 (estimated)
- 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.
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Detailed description
Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week for 2 weeks. They will be evaluated every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YBand(YDT-201N) | Experimental | Device: Yband(YDT-201N)transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications) |
| Sham-Yband(YDT-201N) | Sham comparator | Device: Sham-Yband(YDT-201N)sham-tDCS application 5 days a week for 2 weeks (total of 10 applications) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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
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 sertraline 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 |
|---|---|---|
| Yband(YDT-201N)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) | Device | YBand(YDT-201N) |
| Sham-Yband(YDT-201N)transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) | Device | Sham-Yband(YDT-201N) |
Primary outcome
Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: from baseline to Week 6
Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)
5 secondary outcomes
Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: At 6 weeks after treatment.
Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: At 6 weeks after treatment
Average change in results for 2, 4, 6 weeks after treatment as assessed by the clinician-rated Clinical Global Impression-Severity of Illness Scale (CGISI)
Time frame: At 2 weeks, 4 weeks and 6 weeks after treatment
Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II)
Time frame: At 2 weeks, 4 weeks and 6 weeks after treatment
Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI)
Time frame: At 2 weeks, 4 weeks and 6 weeks after treatment
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 26 Jan 2017.
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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.
Seungwoo Lee study director
Ybrain Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Yband(YDT-201N) in people with Major Depressive Disorder, 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 4 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 26 Jan 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: from baseline to Week 6). 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 26 Jan 2017.