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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • tACS (aperiodic)

Treatment groups

10 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

Brain & Behavior Research Foundation

Collaborator

Michigan State University

Collaborator