RecruitingNot applicable

CARED : A Novel Rapid Treatment Paradigm for Depression

The Carolina Recovery From Depression Protocol (CARED) : A Novel Rapid Treatment Paradigm for Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a one-session treatment combining talk therapy and brain stimulation is practical and helps people with major depression. It is for adults whose depression has not improved enough with at least one antidepressant. Everyone gets talk therapy and magnetic brain stimulation (iTBS), plus either real or fake electrical brain stimulation (tACS).

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18–70, of any gender.
  • Have major depression without bipolar disorder or psychosis, such as seeing or hearing things that are not there.
  • Score at least 14 on the study's depression symptom scale (HDRS-17).
  • Have tried at least one antidepressant without enough symptom relief, and score at least 3 on the study's treatment history scale (MTI).
  • Have no active suicidal thoughts in the past month, and no suicide attempts, actions to prepare for suicide, or major self-harm in the past 2 years.
  • Understand the study's risks and possible benefits, and sign and date a consent form.
  • Be willing and available to follow all study steps.
  • If you can become pregnant, use highly effective birth control approved by the study doctor for at least 1 month before screening and throughout the study.

Who can't join

  • Severe alcohol use disorder or moderate to severe substance use disorder in the past 12 months, not counting tobacco.
  • Any history of bipolar disorder or autism, or a disorder involving psychosis, such as schizophrenia.
  • Starting a mental health medicine, changing its dose, starting a new course of talk therapy, or receiving brain stimulation in the 6 weeks before screening.
  • A history of seizures, except childhood fever seizures or seizures caused by electroconvulsive therapy (ECT); epilepsy in you or your family; or past fainting.
  • A brain or nerve condition that raises study risks or affects results; past brain surgery or brain implants; or no response to past ECT or magnetic brain stimulation (TMS).
  • Metal anywhere in the body; an implanted device that uses electricity; or an implant in the head, neck, or within 30 centimeters of the TMS coil.
  • Being pregnant or breastfeeding, or being in another depression clinical trial.
  • Not speaking English, or having an unstable health condition or another issue that the study doctor believes makes participation unsafe or prevents finishing the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (1)

NC