Pilot Study of Personalized Aperiodic Transcranial Alternating Current Stimulation in Antenatal Depression (PandA-tACS)

Completed · Not applicable

Conditions studied: Antenatal Depression, Major Depressive Disorder, Major Depressive Disorder in Pregnancy, Healthy Controls

In brief

The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach in antenatal depression.

Key facts

Study ID

NCT06979154

Run by

University of North Carolina, Chapel Hill

People needed

6

Starts

2025-08-12

Expected to finish

2026-06-29

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Female aged 18 - 45
• Capacity to understand all relevant risks and potential benefits of the study as determined by study staff (provision of informed consent)
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Low suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the C-SSRS screen and triage version with further exploration of positive responses.
• For healthy control population:
• Use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation, according to NIH Therapeutics Research Program Guidelines.
• Additional for antenatal depression population:
• Between weeks 14-32 of viable singleton pregnancy
• Established obstetric care through UNC
• Pre-identified DSM-5 diagnosis of unipolar, non-psychotic MDD which is confirmed by the DIAMOND
• HDRS-17 score ≥8

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND
• DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND
• Lifetime history of bipolar disorder, as evidenced by DIAMOND
• Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND
• History of autism spectrum disorder
• Initiated any new psychotropic medication in the 6 weeks prior to screening or had a dose change in the preceding 6 weeks
• Initiated a new course of psychotherapy in the 6 weeks preceding screening
• Received any neurostimulation treatment in the 6 weeks preceding screening
• History of seizures (excluding febrile seizures in childhood or Electroconvulsive Therapy (ECT) induced seizures)
• Neurological disorders that would increase risk of participation or present a significant confounder in the opinion of the investigator (for example, dementia, history of stroke, Parkinson's disease, multiple sclerosis, history of traumatic brain injury with prolonged loss of consciousness, ruptured cerebral aneurysm, previous CNS radiation)
• Previously failed to respond to ECT or transcranial magnetic stimulation (TMS)
• Prior brain surgery and/or brain implants
• Implanted medical device that uses electricity
• Currently enrolled in another clinical trial for depression
• Unstable medical disorder or anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the opinion of the Investigator
• Additional for the healthy control population:
• Current pregnancy or lactation (as determined by urine pregnancy test)
• History of depression, as evidenced by DIAMOND
• Additional for the antenatal depression population:
• History of any of the following conditions:
• Diabetes (gestational or general history)
• Pre-term delivery (<37 weeks)
• Eclampsia
• Pre-eclampsia with severe features

Where it is running

• Carolina Center for Neurostimulation — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.