N/A
N=30
Intensive tDCS for MDD: Feasibility Study
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05194267 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9) — 21; 31.5 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial direct current stimulation (tDCS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9) |
21; 31.5 | — |
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.
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT05194267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.