No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 70 with major depressive disorder who are not responding to typical treatments. Participants will receive a combination of therapy and brain stimulation in a single session.
Are You a Good Fit for This Trial?
Rules you outSevere alcohol use disorderBipolar disorderAutism spectrum disorderSchizophrenia spectrum disordersNeurological disordersEpilepsy
You may be able to join if
I am between 18 and 70 years old.
I have been diagnosed with major depressive disorder.
I can understand the risks and benefits of this study.
I have experienced no active suicidal thoughts in the past month.
I have not responded to standard antidepressant treatments.
I will use effective contraception if needed.
I am willing to follow all study procedures.
You may not be able to join if
I have a severe alcohol use disorder in the past year.
I have a history of bipolar disorder.
I have experienced seizures or fainting spells.
I have neurological disorders that may complicate my participation.
I am currently pregnant or breastfeeding.
I have metal implants in my body.
I am enrolled in another clinical trial for depression.
I do not speak English.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. I…
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).
Trial Locations
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Eligibility Criteria
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 …
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.
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