Intensive tDCS for MDD: Feasibility Study

NCT05194267 | Completed Results

• 1 other identifier: 2022-9546
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  T0 (baseline), T1 (1 week after end of treatment) and T2 (one month after the end of the treatment)

Study Arms (1)

Active tDCS

EXPERIMENTAL

Will be receiving active intensive tDCS treatment

Device: transcranial direct current stimulation (tDCS)

Interventions

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

Active tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3J4, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Jean-Phillipe Miron
• Organization: UCSD

jmiron@health.ucsd.edu

514-890-8000

Study Officials

• Jean-Philippe Miron, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label feasibility study

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 18, 2022
• Study Start: February 2, 2022
• Primary Completion: August 16, 2023
• Study Completion: August 16, 2023
• Last Updated: July 28, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)