Actively Recruiting
CARED : A Novel Rapid Treatment Paradigm for Depression
Led by University of North Carolina, Chapel Hill · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
F
Foundation of Hope, North Carolina
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
CARED : A Novel Rapid Treatment Paradigm for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender, aged 18 - 70
- Signed and dated informed consent
- Willingness to comply with study procedures and availability for the study duration
- DSM-5 diagnosis of unipolar, non-psychotic Major Depressive Disorder confirmed by DIAMOND
- Hamilton Depression Rating Scale (HDRS-17) score of 14 or higher
- Low suicide risk: no active suicidal thoughts in the past month and no suicide attempts or significant self-harm in past 2 years
- Ability to understand study risks and benefits (informed consent)
- For people who can become pregnant: use of highly effective contraception for at least 1 month before screening and during study
- History of treatment resistance with at least one antidepressant medication without significant symptom improvement (Maudsley Treatment Inventory score ≥3)
You will not qualify if you...
- Severe alcohol use disorder in past 12 months
- Moderate to severe substance use disorder (except tobacco) in past 12 months
- Lifetime bipolar disorder diagnosis
- Schizophrenia spectrum or other psychotic disorders
- Autism spectrum disorder history
- New psychotropic medication started or dose changed in last 6 weeks
- New psychotherapy started in last 6 weeks
- Neurostimulation treatment in last 6 weeks
- History of seizures (except childhood febrile or ECT-induced seizures)
- Neurological disorders increasing risk or confounding results (e.g., dementia, stroke, Parkinson's, multiple sclerosis, traumatic brain injury with prolonged unconsciousness, ruptured cerebral aneurysm, CNS radiation)
- Failed to respond to electroconvulsive therapy or transcranial magnetic stimulation
- Prior brain surgery or brain implants
- Personal or family history of epilepsy
- Previous fainting or syncope episodes
- Metal implants in brain, skull, or body
- Implantable electrical medical devices or implants within 30 cm of TMS coil
- Current pregnancy or breastfeeding
- Enrolled in another depression clinical trial
- Unstable medical conditions or other factors increasing risk or limiting study compliance
- Non-English speaking individuals due to communication and resource limitations
AI-Screening
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Trial Site Locations
Total: 1 location
1
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
Research Team
F
Flavio Frohlich, PhD
CONTACT
H
Haileigh Taylor, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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