Major Depressive Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEtranscranial direct current stimulation (tDCS)
tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Major unipolar depression for at least 4 weeks meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) * Age between 18 to 65 * Minimum score of 17 on the GRID-Hamilton Depression Rating Scale (GRID-HAMD)
Exclusion criteria
* Bipolar disorder, * Psychosis * Active substance use disorder (in the last 3 months) * Personality disorder * Neurocognitive disorder * High risk of suicide * Major comorbid medical or neurological condition * Pregnancy Medical contraindications to tDCS: * Ferromagnetic material in the skull * Defect in the bone substance of the skull * Dermatological condition (e.g. eczema, psoriasis, urticaria, dermatitis, acne, hyperhidrosis, folliculitis, rosacea, keratosis, herpes, infectious or neoplastic phenomenon, etc.) * Skin lesion on the skull (ex: cuts, abrasions, rash, tattoos on the skull, piercings on the head, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9) | T0 (baseline), T1 (1 week after end of treatment) and T2 (one month after the end of the treatment) | 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: * T1 = 1 week after end of treatment (Day 17) * T2 = 1 month after end of treatment (Day 40) Percentage change was calculated using the formula: ((T\_follow-up - T0) / T0) × 100. A negative value indicates improvement. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Active tDCS | — |
|---|---|---|
| Age at first depressive episode | 26.9 years STANDARD_DEVIATION 12.7 | — |
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 28 Participants | — |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 10.7 | — |
| Education | 15.4 years STANDARD_DEVIATION 2.1 | — |
| Length of current depressive episode | 14.4 months STANDARD_DEVIATION 9.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 28 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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: * T1 = 1 week after end of treatment (Day 17) * T2 = 1 month after end of treatment (Day 40) Percentage change was calculated using the formula: ((T\_follow-up - T0) / T0) × 100. A negative value indicates improvement.
Time frame: T0 (baseline), T1 (1 week after end of treatment) and T2 (one month after the end of the treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active tDCS | Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9) | T1 | 21 percentage of change | Standard Deviation 31.9 |
| Active tDCS | Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9) | T2 | 31.5 percentage of change | Standard Deviation 34.8 |