NCT07572526 tDCS: Sleep to Mood in Depression (S2M-D)
| NCT ID | NCT07572526 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-06-04 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2026-06-04 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine whether changes in sleep consolidation occur during home-based transcranial direct current stimulation (tDCS) in adults with moderate depression and whether these changes are temporally associated with improvements in depressive symptoms.
Eligibility Criteria
Inclusion Criteria: 1. Ability to read and understand study materials in English, as demonstrated by a standard score \>85 on the WRAT-5 Reading Recognition Subtest 2. MADRS-S ≥18 during screening 3. Confirmed diagnosis of MDD, based on clinician interview 4. If taking antidepressant medication, the dose must be stable for at least 30 days prior to pre-screening. 5. Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms OR confirmed acknowledgement and identification of local resources. 6. Able to provide informed consent and comply with study procedures. 7. Access to a quiet space suitable for home-based tDCS stimulation sessions. Exclusion Criteria: 1. Current major medical condition that, in the opinion of the study clinician, would interfere with study participation, safety, or interpretation of study outcomes. 2. Current or past bipolar disorder, psychotic disorder, or current (past 6 months) alcohol or substance use disorder, as determined by clinician assessment at screening. 3. Clinically significant suicidal ideation or behavior, based on clinician assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS). 4. Use of prescription or over-the-counter sleep-promoting medications or initiation of behavioral interventions specifically targeting sleep in the past 30 days from pre-screening. 5. History of seizure disorder or epilepsy. 6. Presence of an active implanted medical device above the neck (e.g., deep brain stimulator, cochlear implant) or non-MRI-compatible metallic implants in the head or neck region. 7. Current use of prescription or over-the-counter sleep medications, or active participation in any behavioral or pharmacologic treatment specifically targeting sleep. 8. Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding o If able to become pregnant, participants will be required to use medically accepted birth control methods, including hormonal methods (e.g., pills, patches, implants), barrier methods (e.g., condoms or diaphragm with spermicide), intrauterine device (IUD), or abstinence. Participants will be advised not to become pregnant during the study.
Contact & Investigator
Giuseppina Pilloni
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT07572526 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07572526 currently recruiting?
Yes, NCT07572526 is actively recruiting participants. Contact the research team at Shayna.Pehel@nyulangone.org for enrollment information.
Where is the NCT07572526 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07572526 clinical trial?
NCT07572526 is sponsored by NYU Langone Health. The principal investigator is Giuseppina Pilloni at NYU Langone Health. The trial plans to enroll 35 participants.