Major Depressive DisorderDepressionDCNCT02530164
Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression
A study testing Transcranial direct current stimulation (tDCS) in people with Major Depressive Disorder and Unipolar Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Treatment is often challenging; an estimated 20-40% of patients do not benefit sufficiently from existing antidepressant interventions including trials of medication and psychotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Unipolar Depression, Depression
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Feb 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 18-65 years of age.
- Primary DSM-5 diagnosis of Major Depression as assessed by the Structured Clinical Interview for DSM-5 Axis I Disorders, Research Version (SCID-5-RV) with a single or recurrent episode with the additional requirements of a current episode with a duration of ≥4 weeks.
- Current depressive episode is less than 5 years duration (the definition of an episode is demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-5 definition of major depressive episode).
- Total HDRS-21 ≥15 at the screening visit.
- The patient did not respond to at least one antidepressant treatment, i.e., a minimum of 1 and a maximum of 4 antidepressant drug trials, of adequate dose and duration (defined as a minimum level of 2 on the ATHF) in the current episode.
- Patient is taking a SSRI of adequate dose and ≥4 weeks (defined as a minimum level of 2 on the ATHF) in the current episode.
- Capable and willing to provide informed consent.
- Negative pregnancy test and willingness to use contraceptive measures during study treatment for women with childbearing potential (i.e <. 2 years post-menopausal)
Who cannot join
- Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
- Acute risk for suicide (MADRS, item 10 score of >4 or as assessed by the C-SSRS, agree to item 4 and/or to item 5).
- High degree of therapy resistance defined as >4 sufficient treatment attempts in the current episode (each attempt with an ATHF score of >3).
- Treatment with electroconvulsive therapy in the present episode.
- Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants).
- Any other relevant psychiatric axis-I- and/or axis-II-disorder.
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- Any relevant instable medical condition.
- History of treatment with tDCS for any disorder.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich
Munich, 80336
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression - A Prospective Multicenter Double Blind Randomized Placebo Controlled Trial (DepressionDC)
Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Treatment is often challenging; an estimated 20-40% of patients do not benefit sufficiently from existing antidepressant interventions including trials of medication and psychotherapy. A 15-25% of patients manifest a chronic, treatment-resistant course of illness, resulting in a need for additional treatment options. Brain stimulation techniques are considered as a promising therapeutic approach in affective disorders like MDD. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that has been largely investigated in experimental neurosciences and tDCS of the prefrontal cortex (PFC) has been proposed as novel treatment in MDD. In the largest 2x2 factorial randomized controlled trial in MDD to date, Brunoni et al. (2013) have shown that tDCS combined with an Selective Serotonin Reuptake Inhibitor (SSRI; sertraline) resulted in an antidepressant efficacy superior to placebo treatment, tDCS alone and sertraline alone.
The purpose of this study is to explore the sustained efficacy and tolerability of repeated tDCS for the treatment of MDD. It is hypothesized that prefrontal tDCS in combination with an SSRI will provoke an antidepressant effect while antidepressant medication alone (sham tDCS) did not. This will be measured by the change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores after 6 weeks of treatment.
In this randomized, placebo-controlled multicenter trial (5 centers involved) patients with a diagnosis of MDD receive a 6-weeks treatment with prefrontal tDCS (anode over electrode position F3, cathode over F4, 5 sessions/week for 4 weeks followed by 2 sessions/week for 2 weeks, 24 treatments in sum, 30min/day, 2mA intensity) or sham tDCS (frequency and duration correspondent active tDCS, ramp in and ramp out periods only without intermittent stimulation), as adjunctive treatment with a SSRI. Follow-up per patient is 3 and 6 months after the last tDCS treatment session. Before, during and after the treatment period different assessment scales will be conducted to record neuropsychological features and the course of the individual symptomatology.
- Conditions
- Major Depressive Disorder, Unipolar Depression, Depression
- Being tested
- Transcranial direct current stimulation (tDCS)
- Keywords
- tDCS, SSRI, transcranial direct current stimulation, non-invasive brain stimulation, randomized controlled trial, prefrontal tDCS, neuromodulation
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, 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
active/sham tDCS as adjunctive treatment with a SSRI
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Active comparator | Not described Receives: Device: Transcranial direct current stimulation (tDCS) |
| sham tDCS | Placebo comparator | Not described Receives: Device: Transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2020
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Keeser, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530164
- Sponsor's protocol ID
- DEP-1483-0152-I
- Acronym
- DepressionDC
- Status last verified
- Jun 2023
- First submitted
- 19 Aug 2015
- Last updated
- 15 Jun 2023
- Results posted
- No
Publications
Padberg F, Kumpf U, Mansmann U, Palm U, Plewnia C, Langguth B, Zwanzger P, Fallgatter A, Nolden J, Burger M, Keeser D, Rupprecht R, Falkai P, Hasan A, Egert S, Bajbouj M. Prefrontal transcranial direct current stimulation (tDCS) as treatment for major depression: study design and methodology of a multicenter triple blind randomized placebo controlled trial (DepressionDC). Eur Arch Psychiatry Clin Neurosci. 2017 Dec;267(8):751-766. doi: 10.1007/s00406-017-0769-y. Epub 2017 Feb 28.
PubMed 28246891Burkhardt G, Kumpf U, Crispin A, Goerigk S, Andre E, Plewnia C, Brendel B, Fallgatter A, Langguth B, Abdelnaim M, Hebel T, Normann C, Frase L, Zwanzger P, Diemer J, Kammer T, Schonfeldt-Lecuona C, Kamp D, Bajbouj M, Behler N, Wilkening A, Nenov-Matt T, Dechantsreiter E, Keeser D, Bulubas L, Palm U, Blankenstein C, Mansmann U, Falkai P, Brunoni AR, Hasan A, Padberg F. Transcranial direct current stimulation as an additional treatment to selective serotonin reuptake inhibitors in adults with major depressive disorder in Germany (DepressionDC): a triple-blind, randomised, sham-controlled, multicentre trial. Lancet. 2023 Aug 12;402(10401):545-554. doi: 10.1016/S0140-6736(23)00640-2. Epub 2023 Jul 3.
PubMed 37414064
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression - A Prospective Multicenter Double Blind Randomized Placebo Controlled Trial (DepressionDC)
- ClinicalTrials.gov ID
- NCT02530164
- Acronym / sponsor ID
- DepressionDC / DEP-1483-0152-I
- Conditions
- Major Depressive Disorder, Unipolar Depression, Depression
- Keywords
- tDCS, SSRI, transcranial direct current stimulation, non-invasive brain stimulation, randomized controlled trial, prefrontal tDCS, neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 20 Aug 2015 (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.
Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Treatment is often challenging; an estimated 20-40% of patients do not benefit sufficiently from existing antidepressant interventions including trials of medication and psychotherapy. A 15-25% of patients manifest a chronic, treatment-resistant course of illness, resulting in a need for additional treatment options. Brain stimulation techniques are considered as a promising therapeutic approach in affective disorders like MDD. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that has been largely investigated in experimental neurosciences and tDCS of the prefrontal cortex (PFC) has been proposed as novel treatment in MDD. In the largest 2x2 factorial randomized controlled trial in MDD to date, Brunoni et al. (2013) have shown that tDCS combined with an Selective Serotonin Reuptake Inhibitor (SSRI; sertraline) resulted in an antidepressant efficacy superior to placebo treatment, tDCS alone and sertraline alone.
The purpose of this study is to explore the sustained efficacy and tolerability of repeated tDCS for the treatment of MDD. It is hypothesized that prefrontal tDCS in combination with an SSRI will provoke an antidepressant effect while antidepressant medication alone (sham tDCS) did not. This will be measured by the change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores after 6 weeks of treatment.
In this randomized, placebo-controlled multicenter trial (5 centers involved) patients with a diagnosis of MDD receive a 6-weeks treatment with prefrontal tDCS (anode over electrode position F3, cathode over F4, 5 sessions/week for 4 weeks followed by 2 sessions/week for 2 weeks, 24 treatments in sum, 30min/day, 2mA intensity) or sham tDCS (frequency and duration correspondent active tDCS, ramp in and ramp out periods only without intermittent stimulation), as adjunctive treatment with a SSRI. Follow-up per patient is 3 and 6 months after the last tDCS treatment session. Before, during and after the treatment period different assessment scales will be conducted to record neuropsychological features and the course of the individual symptomatology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Active comparator | Device: Transcranial direct current stimulation (tDCS) |
| sham tDCS | Placebo comparator | Device: Transcranial direct current stimulation (tDCS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women 18-65 years of age.
- Primary DSM-5 diagnosis of Major Depression as assessed by the Structured Clinical Interview for DSM-5 Axis I Disorders, Research Version (SCID-5-RV) with a single or recurrent episode with the additional requirements of a current episode with a duration of ≥4 weeks.
- Current depressive episode is less than 5 years duration (the definition of an episode is demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-5 definition of major depressive episode).
- Total HDRS-21 ≥15 at the screening visit.
- The patient did not respond to at least one antidepressant treatment, i.e., a minimum of 1 and a maximum of 4 antidepressant drug trials, of adequate dose and duration (defined as a minimum level of 2 on the ATHF) in the current episode.
Key exclusion criteria (9 listed)
- Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
- Acute risk for suicide (MADRS, item 10 score of >4 or as assessed by the C-SSRS, agree to item 4 and/or to item 5).
- High degree of therapy resistance defined as >4 sufficient treatment attempts in the current episode (each attempt with an ATHF score of >3).
- Treatment with electroconvulsive therapy in the present episode.
- Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants).
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)active/sham tDCS as adjunctive treatment with a SSRI | Device | real tDCS, sham tDCS |
Primary outcome
Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline.
Time frame: 6 weeks
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 15 Jun 2023.
- Background: PubMed 28246891Padberg F, Kumpf U, Mansmann U, Palm U, Plewnia C, Langguth B, Zwanzger P, Fallgatter A, Nolden J, Burger M, Keeser D, Rupprecht R, Falkai P, Hasan A, Egert S, Bajbouj M. Prefrontal transcranial direct current stimulation (tDCS) as treatment for major depression: study design and methodology of a multicenter triple blind randomized placebo controlled trial (DepressionDC). Eur Arch Psychiatry Clin Neurosci. 2017 Dec;267(8):751-766. doi: 10.1007/s00406-017-0769-y. Epub 2017 Feb 28.
- Derived from this study: PubMed 37414064Burkhardt G, Kumpf U, Crispin A, Goerigk S, Andre E, Plewnia C, Brendel B, Fallgatter A, Langguth B, Abdelnaim M, Hebel T, Normann C, Frase L, Zwanzger P, Diemer J, Kammer T, Schonfeldt-Lecuona C, Kamp D, Bajbouj M, Behler N, Wilkening A, Nenov-Matt T, Dechantsreiter E, Keeser D, Bulubas L, Palm U, Blankenstein C, Mansmann U, Falkai P, Brunoni AR, Hasan A, Padberg F. Transcranial direct current stimulation as an additional treatment to selective serotonin reuptake inhibitors in adults with major depressive disorder in Germany (DepressionDC): a triple-blind, randomised, sham-controlled, multicentre trial. Lancet. 2023 Aug 12;402(10401):545-554. doi: 10.1016/S0140-6736(23)00640-2. Epub 2023 Jul 3.
- Related InfoLink provided by the sponsor.
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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 Transcranial direct current stimulation (tDCS) in people with Major Depressive Disorder and Unipolar Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 8 inclusion and 9 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 15 Jun 2023. 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 Germany. 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?
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 from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline. (time frame: 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 NCT02530164, which also lists 2 linked publications.
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 15 Jun 2023.