Major Depressive DisorderPhase 2/3NCT01450150
Transcranial Direct Current Stimulation as an Augmenting Intervention for Major Depression
A Phase 2/3 study testing Transcranial Direct Current Stimulation in people with Major Depressive Disorder, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or de-activate neurons in superficial regions of the brain through the induction of weak electric currents in the brain tissue delivered by two scalp electrodes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Oct 2018
- Phase
- Phase 2/3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of a current major depressive disorder (according to the Diagnostic and Statistical Manual, Fourth Edition, Text Revision [DSM-IV-TR])
- Baseline score ≥ 13 on the QIDS-C
- Stable medication regimen (> 4 weeks)
Who cannot join
- Psychotic features in the current episode
- Lifetime history of psychotic disorders and/or bipolar I or II disorders
- Substance or alcohol abuse/dependence in the past 6 months
- Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
- Uncontrolled medical disease (e.g., cardiovascular, renal)
- Pregnancy and/or lactation
- Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, H4H1R3
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) as an Augmenting Intervention for Treatment-Resistant Major Depression: A Randomized, Double-Blind and Sham-Controlled Trial
Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or de-activate neurons in superficial regions of the brain through the induction of weak electric currents in the brain tissue delivered by two scalp electrodes. Initial studies have shown tDCS to be effective for treating major depressive disorder (MDD), although there are negative trials in the specialized literature. One reason for these discrepant results might be that the duration of tDCS treatment in clinical trials to date (up to 2 weeks) is still insufficient to produce consistent clinical improvements. Thus, we intend to assess, in a sample of outpatients with MDD, whether a 3-week adjunctive course of active tDCS over the left dorsolateral prefrontal cortex is associated with a significant clinical improvement when compared to sham tDCS. The investigators hypothesize that subjects receiving active tDCS will present with significantly higher response and remission rates at weeks 3.
- Conditions
- Major Depressive Disorder
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Major Depression, Transcranial Direct Current Stimulation, Randomized, Sham-Controlled Trial, tDCS
- 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.
Transcranial Direct Current StimulationDevice
20-minute daily sessions of 2 mA tDCS for 15 days (Monday to Friday on three consecutive weeks)
Transcranial Direct Current StimulationDevice
The tDCS stimulator will be turned on for 30 seconds only, after which it will be gradually decreased and then turned off for the remainder of the 20-minute daily sessions for 15 days (Monday to Friday on three consecutive weeks).
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Not described Receives: Device: Transcranial Direct Current Stimulation |
| Sham tDCS | Sham comparator | Not described Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C)
Response to treatment is defined as a ≥ 50% reduction in pretreatment symptoms severity at as measured by the mean QIDS-C score. Remission is defined as a QIDS-C score ≤ 5
Measured: week 4
Secondary outcomes (2)
21-item Hamilton Depression Rating Scale (HAM-D21)
Response to treatment is defined as a ≥ 50% reduction in the scores of the HAM-D21. Remission is defined as a HAM-D21 score ≤ 8
Measured: week 4
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Response is defined as a ≥ 50% reduction in the scores of the QIDS-SR. Remission is defined as a QIDS-SR score ≤ 5
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startJan 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCELO T. BERLIM, Douglas Mental Health University Institute
- Investigators
- Marcelo T. Berlim, MD, MSc, Principal investigator, McGill University & Douglas Mental Health University Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450150
- Sponsor's protocol ID
- tDCS-ERB08/04-2011
- Status last verified
- Jan 2016
- First submitted
- 9 Oct 2011
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nitsche MA, Boggio PS, Fregni F, Pascual-Leone A. Treatment of depression with transcranial direct current stimulation (tDCS): a review. Exp Neurol. 2009 Sep;219(1):14-9. doi: 10.1016/j.expneurol.2009.03.038. Epub 2009 Apr 5.
PubMed 19348793Murphy DN, Boggio P, Fregni F. Transcranial direct current stimulation as a therapeutic tool for the treatment of major depression: insights from past and recent clinical studies. Curr Opin Psychiatry. 2009 May;22(3):306-11. doi: 10.1097/YCO.0b013e32832a133f.
PubMed 19339889Arul-Anandam AP, Loo C. Transcranial direct current stimulation: a new tool for the treatment of depression? J Affect Disord. 2009 Oct;117(3):137-45. doi: 10.1016/j.jad.2009.01.016. Epub 2009 Feb 7.
PubMed 19201483Boggio PS, Rigonatti SP, Ribeiro RB, Myczkowski ML, Nitsche MA, Pascual-Leone A, Fregni F. A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression. Int J Neuropsychopharmacol. 2008 Mar;11(2):249-54. doi: 10.1017/S1461145707007833. Epub 2007 Jun 11.
PubMed 17559710
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) as an Augmenting Intervention for Treatment-Resistant Major Depression: A Randomized, Double-Blind and Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT01450150
- Acronym / sponsor ID
- tDCS-ERB08/04-2011
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depression, Transcranial Direct Current Stimulation, Randomized, Sham-Controlled Trial, tDCS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 12 Oct 2011 (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.
Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or de-activate neurons in superficial regions of the brain through the induction of weak electric currents in the brain tissue delivered by two scalp electrodes. Initial studies have shown tDCS to be effective for treating major depressive disorder (MDD), although there are negative trials in the specialized literature. One reason for these discrepant results might be that the duration of tDCS treatment in clinical trials to date (up to 2 weeks) is still insufficient to produce consistent clinical improvements. Thus, we intend to assess, in a sample of outpatients with MDD, whether a 3-week adjunctive course of active tDCS over the left dorsolateral prefrontal cortex is associated with a significant clinical improvement when compared to sham tDCS. The investigators hypothesize that subjects receiving active tDCS will present with significantly higher response and remission rates at weeks 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Transcranial Direct Current Stimulation |
| Sham tDCS | Sham comparator | Device: Transcranial Direct Current Stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of a current major depressive disorder (according to the Diagnostic and Statistical Manual, Fourth Edition, Text Revision [DSM-IV-TR])
- Baseline score ≥ 13 on the QIDS-C
- Stable medication regimen (> 4 weeks)
Key exclusion criteria (7 listed)
- Psychotic features in the current episode
- Lifetime history of psychotic disorders and/or bipolar I or II disorders
- Substance or alcohol abuse/dependence in the past 6 months
- Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
- Uncontrolled medical disease (e.g., cardiovascular, renal)
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 Stimulation20-minute daily sessions of 2 mA tDCS for 15 days (Monday to Friday on three consecutive weeks) | Device | Active tDCS |
| Transcranial Direct Current StimulationThe tDCS stimulator will be turned on for 30 seconds only, after which it will be gradually decreased and then turned off for the remainder of the 20-minute daily sessions for 15 days (Monday to Friday on three consecutive weeks). | Device | Sham tDCS |
Primary outcome
Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C)
Time frame: week 4
Response to treatment is defined as a ≥ 50% reduction in pretreatment symptoms severity at as measured by the mean QIDS-C score. Remission is defined as a QIDS-C score ≤ 5
2 secondary outcomes
21-item Hamilton Depression Rating Scale (HAM-D21)
Time frame: week 4
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Time frame: week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Background: PubMed 19348793Nitsche MA, Boggio PS, Fregni F, Pascual-Leone A. Treatment of depression with transcranial direct current stimulation (tDCS): a review. Exp Neurol. 2009 Sep;219(1):14-9. doi: 10.1016/j.expneurol.2009.03.038. Epub 2009 Apr 5.
- Background: PubMed 19339889Murphy DN, Boggio P, Fregni F. Transcranial direct current stimulation as a therapeutic tool for the treatment of major depression: insights from past and recent clinical studies. Curr Opin Psychiatry. 2009 May;22(3):306-11. doi: 10.1097/YCO.0b013e32832a133f.
- Background: PubMed 19201483Arul-Anandam AP, Loo C. Transcranial direct current stimulation: a new tool for the treatment of depression? J Affect Disord. 2009 Oct;117(3):137-45. doi: 10.1016/j.jad.2009.01.016. Epub 2009 Feb 7.
- Background: PubMed 17559710Boggio PS, Rigonatti SP, Ribeiro RB, Myczkowski ML, Nitsche MA, Pascual-Leone A, Fregni F. A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression. Int J Neuropsychopharmacol. 2008 Mar;11(2):249-54. doi: 10.1017/S1461145707007833. Epub 2007 Jun 11.
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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.
Marcelo T. Berlim, MD, MSc principal investigator
McGill University & Douglas Mental Health University Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Transcranial Direct Current Stimulation in people with Major Depressive Disorder, run by Douglas Mental Health University Institute at 1 site in Canada.
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 7 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 20 Jan 2016. 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 Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo T. Berlim, MD, MSc (514-761-6131, nrc.douglas@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C) (time frame: week 4). 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 NCT01450150, which also lists 4 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 20 Jan 2016; AzTrials last refreshed its copy on 29 Oct 2026.