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This will be a prospective, open-label, single-arm study to determine the safety and feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for major depressive disorder (MDD). Participants will be age 18-65 with a diagnosis of unipolar MDD. Participants will receive an intensive treatment of tDCS over a 10-day treatment period and complete follow-up assessments at the end of treatment, 1, and 4 weeks post-treatment.
This will be a prospective, open-label, single-arm study to determine the safety and feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for major depressive disorder (MDD). Secondary objective is to gather preliminary data on the clinical effects of the protocol. After assessment and inclusion into the study, participants will receive up to 50 tDCS sessions over 10 days.
Study procedures:
Daily assessments: brief questions before and after each tDCS session to evaluate potential adverse events as well as a verbal rating scale for pain.
Questionnaires : a battery of mood questionnaires will be completed to inform findings regarding clinical effects of the treatment.
Cognitive measures: a short cognitive assessment will be completed to inform findings regarding cognitive safety of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Will be receiving active intensive tDCS treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation (tDCS) | Device | tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9) | This outcome reflects the percentage change in depressive symptom severity as measured by the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale assessing depressive symptoms over the past 2 weeks. Each item is scored from 0 ("Not at all") to 3 ("Nearly every day"), with a total score ranging from 0 to 27. Higher scores indicate more severe depression. Percentage change from baseline (T0) was calculated at two follow-up timepoints:
| T0 (baseline), T1 (1 week after end of treatment) and T2 (one month after the end of the treatment) |
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Inclusion Criteria:
Exclusion Criteria:
Medical contraindications to tDCS:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Miron, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec | H2X 3J4 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | Will be receiving active intensive tDCS treatment transcranial direct current stimulation (tDCS): tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | Will be receiving active intensive tDCS treatment transcranial direct current stimulation (tDCS): tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9) | This outcome reflects the percentage change in depressive symptom severity as measured by the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale assessing depressive symptoms over the past 2 weeks. Each item is scored from 0 ("Not at all") to 3 ("Nearly every day"), with a total score ranging from 0 to 27. Higher scores indicate more severe depression. Percentage change from baseline (T0) was calculated at two follow-up timepoints:
| Posted | Mean | Standard Deviation | percentage of change | T0 (baseline), T1 (1 week after end of treatment) and T2 (one month after the end of the treatment) |
|
From Day 1 of treatment (T0) to one-month post-treatment follow-up (T2, Day 40)
Same definition than from clinicaltrials.org
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tDCS | Will be receiving active intensive tDCS treatment transcranial direct current stimulation (tDCS): tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling, itching, or burning sensation during stimulation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Phillipe Miron | UCSD | 514-890-8000 | 26489 | jmiron@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2022 | Apr 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Open label feasibility study
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| Length of current depressive episode | Mean | Standard Deviation | months |
|
| Age at first depressive episode | Mean | Standard Deviation | years |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 28 |
| 28 |
| Skin redness after stimulation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Contact dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dizziness/light-headedness | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Electric shock-like sensations | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |