Trial Outcomes & Findings for Intensive tDCS for MDD: Feasibility Study (NCT NCT05194267)

NCT ID: NCT05194267

Last Updated: 2025-07-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

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

Results posted on

2025-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active tDCS n=28 Participants 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
Age, Categorical <=18 years	0 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=28 Participants
Age, Categorical >=65 years	0 Participants n=28 Participants
Age, Continuous	42.6 years STANDARD_DEVIATION 10.7 • n=28 Participants
Sex: Female, Male Female	18 Participants n=28 Participants
Sex: Female, Male Male	10 Participants n=28 Participants
Education	15.4 years STANDARD_DEVIATION 2.1 • n=28 Participants
Length of current depressive episode	14.4 months STANDARD_DEVIATION 9.6 • n=28 Participants
Age at first depressive episode	26.9 years STANDARD_DEVIATION 12.7 • n=28 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Active tDCS n=28 Participants 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
Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9) T1	21 percentage of change Standard Deviation 31.9
Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9) T2	31.5 percentage of change Standard Deviation 34.8

Adverse Events

Active tDCS

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active tDCS n=28 participants at risk 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
Skin and subcutaneous tissue disorders Tingling, itching, or burning sensation during stimulation	100.0% 28/28 • From Day 1 of treatment (T0) to one-month post-treatment follow-up (T2, Day 40) Same definition than from clinicaltrials.org
Skin and subcutaneous tissue disorders Skin redness after stimulation	100.0% 28/28 • From Day 1 of treatment (T0) to one-month post-treatment follow-up (T2, Day 40) Same definition than from clinicaltrials.org
Nervous system disorders Headache	67.9% 19/28 • From Day 1 of treatment (T0) to one-month post-treatment follow-up (T2, Day 40) Same definition than from clinicaltrials.org
Skin and subcutaneous tissue disorders Contact dermatitis	64.3% 18/28 • From Day 1 of treatment (T0) to one-month post-treatment follow-up (T2, Day 40) Same definition than from clinicaltrials.org
General disorders Fatigue	57.1% 16/28 • From Day 1 of treatment (T0) to one-month post-treatment follow-up (T2, Day 40) Same definition than from clinicaltrials.org
Skin and subcutaneous tissue disorders Burning sensation	25.0% 7/28 • From Day 1 of treatment (T0) to one-month post-treatment follow-up (T2, Day 40) Same definition than from clinicaltrials.org
Nervous system disorders Dizziness/light-headedness	14.3% 4/28 • From Day 1 of treatment (T0) to one-month post-treatment follow-up (T2, Day 40) Same definition than from clinicaltrials.org
Psychiatric disorders Insomnia	10.7% 3/28 • From Day 1 of treatment (T0) to one-month post-treatment follow-up (T2, Day 40) Same definition than from clinicaltrials.org
Skin and subcutaneous tissue disorders Electric shock-like sensations	7.1% 2/28 • From Day 1 of treatment (T0) to one-month post-treatment follow-up (T2, Day 40) Same definition than from clinicaltrials.org

Additional Information

Jean-Phillipe Miron

UCSD

Phone: 514-890-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place