Depressive Disorder, MajorNESBIDNCT04159012
NESBID: Neuro-Stimulation of the Brain in Depression
A study testing Transcranial direct current stimulation in people with Depressive Disorder, Major and Depressive Disorder, Treatment-Resistant, run by University of Alberta at 1 site in Canada.
Trial summary
In Canada, approximately 20% of patients with Major Depressive Disorder (MDD) have treatment-resistance and fail to respond to trials of pharmacotherapy or psychotherapy. Although the treatment of choice has historically consisted of electroconvulsive therapy (ECT), this is not always feasible or practical, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Transcranial Direct Current Stimulation
- 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
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 15 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently suffering from an MDE with a score on the Montgomery-Åsberg Depression Rating Scale (MADRS) greater than 34 (signifying severe depression)
- Have ultra treatment resistant MDD (defined as failure to remit despite adequate trials with five antidepressants, or failure to remit with ECT, or failure to remit with ketamine)
Who cannot join
- Have been diagnosed with psychosis, an addiction disorder (other than nicotine), borderline personality disorder, or antisocial personality disorder, as these conditions could interfere with adherence to the study protocol
- Are currently using a herbal compound or known NMDA-modulating agent, as these substances could interfere with the induction of LTP and thereby limit the effectiveness of tDCS
- Are pregnant, as tDCS has not been adequately studied in this population
- Have an electronic implant, cardiac dysrhythmia, seizure disorder, neurological disorder, or neurosurgical history, as the safety of electrical stimulation with tDCS cannot be assured given these comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NESBID: Neuro-Stimulation of the Brain in Depression. A Randomized, Controlled Clinical Trial of Transcranial Direct Current Stimulation Augmentation, as Compared to Sham Therapy, in the Treatment of Ultra-resistant Major Depressive Disorder
In Canada, approximately 20% of patients with Major Depressive Disorder (MDD) have treatment-resistance and fail to respond to trials of pharmacotherapy or psychotherapy. Although the treatment of choice has historically consisted of electroconvulsive therapy (ECT), this is not always feasible or practical, and carries a risk of side-effects that may be unacceptable to certain patients.
In this pragmatic, multi-site, placebo-controlled and double-blinded clinical trial, participants with ultra treatment-resistant MDD will be randomized to receive either active or sham transcranial direct current stimulation in addition to their usual treatment. Ultra treatment-resistant depression will be operationally defined as MDD that has failed to respond to at least five previous trials of antidepressants at sufficient doses, or ECT, or ketamine. Patients will receive a total of 30 active or sham treatment sessions (5 per week), for 30 minutes per session. In both groups, the anode will be placed over the left dorsolateral prefrontal cortex (position F3), and the cathode over the right dorsolateral prefrontal cortex (position F4). Patients in the sham group will receive electrical stimulation at 2 mA for less than 30 seconds, whereas patients in the active group will receive that level of stimulation for the entire duration of treatment.
The study's primary outcome is the change in score on a clinician-graded depression inventory (the Montgomery-Asberg Depression Rating Scales). Secondary outcomes include change in scores on a self-administered depression rating scale and measurement of function scale. Information on language ability will also be collected, as will data on side-effects of treatment. Scores will be collected before the trial start, after every 10 sessions, and one month after trial completion.
- Conditions
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Transcranial Direct Current Stimulation, Electric Stimulation Therapy
- Being tested
- Transcranial direct current stimulation
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Also called Sooma tDCS
A Sooma transcranial direct current stimulator, using carbon electrodes, a reusable cap (to promote reproducible electrode placement), and disposable sponges that will be soaked in normal saline.
The anode will be positioned over the left dorsolateral prefrontal cortex (position F3 on the 10-20 the International EEG system), and the cathode will be positioned over the right dorsolateral prefrontal cortex (position F4).
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial direct current stimulation | Experimental | Active transcranial direct current stimulation (tDCS), delivered at 2 mA and for 30 minutes, on sequential weekdays, for a total of 30 sessions. Participants will continue to receive their usual pharmacotherapy and psychotherapy. Receives: Device: Transcranial direct current stimulation |
| Sham transcranial direct current stimulation | Sham comparator | Sham transcranial direct current stimulation (tDCS), which will ramp up to 2 mA over 17 s, and then ramp down to and remain at 0.3 mA for the remainder of the 30 minute session. The short period of active stimulation is included to stimulate the somatic sensations of active therapy. The trickle current at 0.3 mA is necessary to measure electrode contact and prevent investigators from deducing that the device is no longer active. Participants will receive the sham therapy on sequential weekdays for a total of 30 sessions. Participants will continue to receive their usual pharmacotherapy and psychotherapy. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
An observer-assessed score of depression severity. The total is scored from 0 to 60, with higher scores representing greater depression severity
Measured: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Secondary outcomes (8)
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)
A participant-assessed measurement of depression severity. The total is scored from 0 to 27, with higher scores indicating greater depression severity.
Measured: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Change in the World Health Organization Disability Assessment Schedule score
Measured: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Exploratory language analysis
Change in language characteristics, based on recorded interviews
Measured: Baseline and after 6 weeks/trial completion
Lexical decision making task
Performance on a task in which patients much distinguish real from fictitious words as quickly as possible
Measured: Baseline and after 6 weeks/trial completion
tDCS adverse events scale
Adverse events as assessed on a scale derived from a systematic review on side effects that may be associated with tDCS
Measured: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
FIBSER
Frequency, Intensity, and Burden of Side-Effects Rating Scale
Measured: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
PRISE
Patient-Rated Inventory of Side-Effects Scale
Measured: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
YMRS
Young Mania Rating Scale, included to capture treatment-related manic or hypomanic switches
Measured: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start1 Sep 2020
- Primary completion15 Nov 2025
- Study completion15 Nov 2025
Why it stopped: Logistical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Serdar M Dursun, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159012
- Sponsor's protocol ID
- TDCS2019
- Acronym
- NESBID
- Status last verified
- Jan 2026
- First submitted
- 8 Jul 2019
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
Suleman R, Tucker BV, Dursun SM, Demas ML. The Neurostimulation of the Brain in Depression Trial: Protocol for a Randomized Controlled Trial of Transcranial Direct Current Stimulation in Treatment-Resistant Depression. JMIR Res Protoc. 2021 Mar 17;10(3):e22805. doi: 10.2196/22805.
PubMed 33729165
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NESBID: Neuro-Stimulation of the Brain in Depression. A Randomized, Controlled Clinical Trial of Transcranial Direct Current Stimulation Augmentation, as Compared to Sham Therapy, in the Treatment of Ultra-resistant Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04159012
- Acronym / sponsor ID
- NESBID / TDCS2019
- Conditions
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Transcranial Direct Current Stimulation, Electric Stimulation Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 12 Nov 2019 (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 Canada, approximately 20% of patients with Major Depressive Disorder (MDD) have treatment-resistance and fail to respond to trials of pharmacotherapy or psychotherapy. Although the treatment of choice has historically consisted of electroconvulsive therapy (ECT), this is not always feasible or practical, and carries a risk of side-effects that may be unacceptable to certain patients.
In this pragmatic, multi-site, placebo-controlled and double-blinded clinical trial, participants with ultra treatment-resistant MDD will be randomized to receive either active or sham transcranial direct current stimulation in addition to their usual treatment. Ultra treatment-resistant depression will be operationally defined as MDD that has failed to respond to at least five previous trials of antidepressants at sufficient doses, or ECT, or ketamine. Patients will receive a total of 30 active or sham treatment sessions (5 per week), for 30 minutes per session. In both groups, the anode will be placed over the left dorsolateral prefrontal cortex (position F3), and the cathode over the right dorsolateral prefrontal cortex (position F4). Patients in the sham group will receive electrical stimulation at 2 mA for less than 30 seconds, whereas patients in the active group will receive that level of stimulation for the entire duration of treatment.
The study's primary outcome is the change in score on a clinician-graded depression inventory (the Montgomery-Asberg Depression Rating Scales). Secondary outcomes include change in scores on a self-administered depression rating scale and measurement of function scale. Information on language ability will also be collected, as will data on side-effects of treatment. Scores will be collected before the trial start, after every 10 sessions, and one month after trial completion.
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 |
|---|---|---|
| Active transcranial direct current stimulation | Experimental | Device: Transcranial direct current stimulationActive transcranial direct current stimulation (tDCS), delivered at 2 mA and for 30 minutes, on sequential weekdays, for a total of 30 sessions. Participants will continue to receive their usual pharmacotherapy and psychotherapy. |
| Sham transcranial direct current stimulation | Sham comparator | Device: Transcranial direct current stimulationSham transcranial direct current stimulation (tDCS), which will ramp up to 2 mA over 17 s, and then ramp down to and remain at 0.3 mA for the remainder of the 30 minute session. The short period of active stimulation is included to stimulate the somatic sensations of active therapy. The trickle current at 0.3 mA is necessary to measure electrode contact and prevent investigators from deducing that the device is no longer active. Participants will receive the sham therapy on sequential weekdays for a total of 30 sessions. Participants will continue to receive their usual pharmacotherapy and psychotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently suffering from an MDE with a score on the Montgomery-Åsberg Depression Rating Scale (MADRS) greater than 34 (signifying severe depression)
- Have ultra treatment resistant MDD (defined as failure to remit despite adequate trials with five antidepressants, or failure to remit with ECT, or failure to remit with ketamine)
Key exclusion criteria (4 listed)
- Have been diagnosed with psychosis, an addiction disorder (other than nicotine), borderline personality disorder, or antisocial personality disorder, as these conditions could interfere with adherence to the study protocol
- Are currently using a herbal compound or known NMDA-modulating agent, as these substances could interfere with the induction of LTP and thereby limit the effectiveness of tDCS
- Are pregnant, as tDCS has not been adequately studied in this population
- Have an electronic implant, cardiac dysrhythmia, seizure disorder, neurological disorder, or neurosurgical history, as the safety of electrical stimulation with tDCS cannot be assured given these comorbidities
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 stimulationAlso: Sooma tDCSA Sooma transcranial direct current stimulator, using carbon electrodes, a reusable cap (to promote reproducible electrode placement), and disposable sponges that will be soaked in normal saline. The anode will be positioned over the left dorsolateral prefrontal cortex (position F3 on the 10-20 the International EEG system), and the cathode will be positioned over the right dorsolateral prefrontal cortex (position F4). | Device | Active transcranial direct current stimulation, Sham transcranial direct current stimulation |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
An observer-assessed score of depression severity. The total is scored from 0 to 60, with higher scores representing greater depression severity
8 secondary outcomes
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)
Time frame: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Exploratory language analysis
Time frame: Baseline and after 6 weeks/trial completion
Lexical decision making task
Time frame: Baseline and after 6 weeks/trial completion
tDCS adverse events scale
Time frame: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
FIBSER
Time frame: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
PRISE
Time frame: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
YMRS
Time frame: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 33729165Suleman R, Tucker BV, Dursun SM, Demas ML. The Neurostimulation of the Brain in Depression Trial: Protocol for a Randomized Controlled Trial of Transcranial Direct Current Stimulation in Treatment-Resistant Depression. JMIR Res Protoc. 2021 Mar 17;10(3):e22805. doi: 10.2196/22805.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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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.
Serdar M Dursun, MD, PhD principal investigator
University of Alberta
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 in people with Depressive Disorder, Major and Depressive Disorder, Treatment-Resistant, run by University of Alberta 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 21 Jan 2026. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion). 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 NCT04159012, which also lists 1 linked publication.
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 21 Jan 2026.