An interventional study of Active Transcranial Direct Current Stimulation (tDCS) and Sham Transcranial Direct Current Stimulation (tDCS) in Depression, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Other
Among 25 studies in Depression by NYU Langone Health — 8 open to participants now, 10 under way, none of them phase 3. Depression · NYU Langone Health.
Among the 25 studies in Depression by NYU Langone Health, this one is the 5th largest by planned enrollment of the 22 interventional ones, is one of 3 that started in 2025, is one of 12 with no phase, and was the 20th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 100 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →8 of the 25 studies in Depression by NYU Langone Health are open now, in 2 countries. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →25 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2025.
Median enrollment 33 across the 22 interventional studies, 30 across the 3 observational. Of the 11 that completed or were terminated, 7 (64%) have results posted.
NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
6 of the studies in Depression by NYU Langone Health that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06004414NYU Langone HealthSilverCloud as a School-Based Intervention for Vulnerable Youth | 2026-12-31 |
| NCT07111390NYU Langone HealthFeasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD) | 2027-01-01 |
| NCT06087159NYU Langone HealthPromoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda | 2027-08-01 |
| NCT05082181NYU Langone HealthTelephone-Based Support Programs for People With Epilepsy | 2027-08-31 |
| NCT06455527NYU Langone HealthHeart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS) | 2027-11-01 |
Among the 25 studies in Depression by NYU Langone Health, from their registry updates:
This technology development project will be informed and guided by initial data collection of human subject data. For this purpose, the investigators will recruit n=100 people with mild to moderate depression in a double-blinded, parallel-arm, sham-controlled data collection period administered at home and using the investigator's remotely supervised (RS) tDCS protocol. Enrolled participants will complete 10 days of 30-minute tDCS (2.0, DLPFC left anodal) using the RS-tDCS protocol. During each daily session, standard HR and impedance-based HR (i-HR), obtained from the tDCS headset, will be collected to identify a possible marker of response to tDCS in depression. Participants will be randomized 2:1 to active vs. sham tDCS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the Active tDCS arm will complete 10 sessions of 30-minute active remotely supervised (RS)-tDCS with chest strap and impedance-based HRV data collection over the course of approximately 2-4 weeks.
Device: Active Transcranial Direct Current Stimulation (tDCS)
Participants randomized to the Active tDCS arm will complete 10 sessions of 30-minute sham RS-tDCS with chest strap and impedance-based HRV data collection over the course of approximately 2-4 weeks.
Device: Sham Transcranial Direct Current Stimulation (tDCS)
tDCS will be delivered using the 1x1 Mini CT tDCS device. For active tDCS, the device is programmed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout the session (29 minutes), and then ramp down (for 30 seconds) at the end. Participants will receive 10 sessions of tDCS over the course of this study on weekdays (M-F).
Sham tDCS will be delivered using the 1x1 Mini CT tDCS device. For sham tDCS, the device is programmed to ramp up to 2.0 mA (for 30 seconds) followed by a ramp down (30 seconds), with no current delivery for 28 minutes, and then ramp up (for 30 seconds) and down (for 30 seconds) at the end. Participants will receive 10 sessions of sham tDCS over the course of this study on weekdays (M-F).
Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor
HR will be measured using Polar H10 Chest Monitor at each daily tDCS session.
Time frame: Up to Week 4
Average HR Measured Using i-HR Data Logger
HR will be measured using an impedance-based HR (i-HR) data logger attached to the Mini-CT tDCS device at each daily tDCS session.
Time frame: Up to Week 4
Change in Montgomery Ӓsberg Depression Rating Scale (MADRS) Score
MADRS is a 10-item assessment of severity of depressive episodes in patients with mood disorders. Each item is rated on a scale from 0-6. The total score is the sum of responses and ranges from 0-60; higher scores indicate greater severity of depressive episodes.
Time frame: Baseline, End of Intervention (Up to Week 4)
Change in State-Trait Anxiety Inventory for Adults (STAI): State Score
STAI is a 40-item questionnaire measuring state and trait anxiety. Each item is rated on a 4-point Likert scale. The range of possible scores for state anxiety ranges from a minimum score of 20 to a maximum score of 80; higher scores indicate greater state anxiety.
Time frame: Baseline, End of Intervention (Up to Week 4)
Change in State-Trait Anxiety Inventory for Adults (STAI): Trait Score
STAI is a 40-item questionnaire measuring state and trait anxiety. Each item is rated on a 4-point Likert scale. The range of possible scores for trait anxiety ranges from a minimum score of 20 to a maximum score of 80; higher scores indicate greater trait anxiety.
Time frame: Baseline, End of Intervention (Up to Week 4)
Change in Positive and Negative Affect Schedule (PANAS-SF): Positive Affect Score
PANAS-SF is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect. Each item is rated on a scale from 1 (very slightly or not at all) to 5 (extremely). The total positive affect score is the sum of affect item responses and ranges from 10 - 50; higher scores represent higher levels of positive affect.
Time frame: Baseline, End of Intervention (Up to Week 4)
Change in Positive and Negative Affect Schedule (PANAS-SF): Negative Affect Score
PANAS-SF is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect. Each item is rated on a scale from 1 (very slightly or not at all) to 5 (extremely). The total negative affect score is the sum of negative item responses and ranges from 10 - 50; lower scores represent lower levels of negative affect.
Time frame: Baseline, End of Intervention (Up to Week 4)
Plan to share: Yes — The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Giuseppina.Pilloni@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposes to use the data will be granted access upon reasonable request. Requests should be directed to Giuseppina.Pilloni@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Nov 2027, 33 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 33 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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