Health Trials

CARED : A Novel Rapid Treatment Paradigm for Depression

ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of North Carolina, Chapel Hill

About this trial

The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical treatments for Major Depressive Disorder. In this trial, participants will receive psychotherapy, Intermittent Theta Burst Stimulation Transcranial Magnetic Stimulation (iTBS), and either active or sham (placebo) Transcranial Alternating Current Stimulation (tACS).

Eligibility criteria

Qualifiers

Any gender, aged 18 - 70

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

DSM-5 diagnosis of unipolar, non-psychotic MDD as evidenced by the Diagnostic Interview for Anxiety, Mood, and Obsessive-Compulsive and Related Neuropsychiatric Disorders (DIAMOND)

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

  • Intermittent Theta Burst Stimulation (iTBS)
  • Transcranial Alternating Current Stimulation (tACS)
  • Psychotherapy
  • Sham (Placebo) Transcranial Alternating Current Stimulation (tACS)

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

Foundation of Hope, North Carolina

Collaborator

Source ClinicalTrials.gov