Chapel Hill, NCNCT07507370Now EnrollingIRB Ready

Major Depressive Disorder Clinical Trial in Chapel Hill, NC

Access cutting-edge major depressive disorder treatment through this clinical trial at a research site in Chapel Hill. Study-provided care at no cost to qualified participants.

Sponsored by University of North Carolina, Chapel Hill

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Expert Care in Chapel Hill

Access major depressive disorder specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related major depressive disorder treatment provided free

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Check if you qualify for this major depressive disorder clinical trial in Chapel Hill, NC

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Chapel Hill

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Chapel Hill site if eligible
  4. 4Begin participation

About This Major Depressive Disorder Study in Chapel Hill

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).

Sponsor: University of North Carolina, Chapel Hill

Who Can Participate

Inclusion Criteria

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)
HDRS-17 score ≥14
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 Columbia-Suicide Severity Rating Scale (C-SSRS) screen and triage version with further exploration of positive responses.
Capacity to understand all relevant risks and potential benefits of the study (informed consent).
For people of childbearing potential: use of highly effective contraception as determined by the Investigator for at least 1 month prior to screening and agreement to use such a method during study participation
History of treatment resistance as indicated by previously or currently not achieving clinically significant symptom reduction on at least one antidepressant medication. This will be evaluated using the Maudsley Treatment Inventory (MTI). Participants with scores greater than or equal to 3 on the MTI will be included.

Exclusion Criteria

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 (self-reported by participants)
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
Personal or familia history of epilepsy
Previous fainting spells or syncope
Metal in the brain, skull or elsewhere in the body
Implanted medical device that uses electricity and any implanted devices in other areas of the head or neck, or implants located \< 30cm from the position of the TMS coil
Current pregnancy or lactation
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
Non-English speaking individuals are excluded because the ability to accurately and completely communicate study information, answer questions about the study, and obtain consent in the English language are necessary, and due to resource constraints it is not feasible to engage an interpreter for language services.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chapel Hill?

Yes, this clinical trial (NCT07507370) has an active research site in Chapel Hill, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Major Depressive Disorder Treatment Options in Chapel Hill, NC

If you're searching for major depressive disorder treatment options in Chapel Hill, NC, this clinical trial (NCT07507370) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chapel Hill research site is actively enrolling participants for this clinical trial. You'll receive care from experienced major depressive disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all major depressive disorder clinical trials near you to find additional studies recruiting in your area.

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