Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3J4, Canada
NCT Number: NCT05194267
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Montreal, Quebec, H2X 3J4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Medical contraindications to tDCS:
tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression
Time frame: 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:
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Intensive Transcranial Direct Current Stimulation in the Treatment of Major Depression: Feasibility Study
Acronym: tDCSintensif
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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