tDCS: Sleep to Mood in Depression (S2M-D)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNYU Langone Health
About this trial
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
Qualifiers
Ability to read and understand study materials in English, as demonstrated by a standard score >85 on the WRAT-5 Reading Recognition Subtest
MADRS-S ≥18 during screening
Confirmed diagnosis of MDD, based on clinician interview
If taking antidepressant medication, the dose must be stable for at least 30 days prior to pre-screening.
Disqualifiers
Current major medical condition that, in the opinion of the study clinician, would interfere with study participation, safety, or interpretation of study outcomes.
Current or past bipolar disorder, psychotic disorder, or current (past 6 months) alcohol or substance use disorder, as determined by clinician assessment at screening.
Clinically significant suicidal ideation or behavior, based on clinician assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
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.
Trial design
Treatments tested in this trial
- transcranial direct current stimulation (tDCS)
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
NYU Langone Health
Lead sponsor
Zabara Foundation
Collaborator
Source ClinicalTrials.gov