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Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic 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 65 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

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In the second session, participants complete a functional magnetic resonance imaging (MRI) session in which they complete three different reward-based decision-making tasks."
  • "After the MRI session, participants are randomized into one of three parallel arms to receive five consecutive days of cross-frequency transcranial alternating current stimulation (CF-tACS) in either delta-beta, control-frequency (theta-gamma), or placebo (sham) CF-tACS."
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 stimulation given for 5 days in a row affects the brain activity it targets. It is for adults currently having major depression with high levels of anhedonia, or trouble seeking and feeling pleasure.

Anhedonia, the inability to seek-out and experience pleasure, is a common symptom in depression that predicts treatment-resistance and is sometimes exacerbated by first-line antidepressants. In our previous research, we found that anhedonia decreases goal-directed behavior and its related neural activity. In this study, we will investigate target engagement from five-consecutive days of stimulation for participants that are within a unipolar major depressive episode and also have high symptoms of anhedonia.

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

Eligibility

Who can join

  • Be 18 to 65 years old.
  • Be able to understand and agree to join the study.
  • Have normal vision, with glasses or contacts if needed.
  • Be willing to follow all study steps and be available for the whole study.
  • Speak and understand English.
  • Have low suicide risk: a score below 3 on the HAM-D suicide question and no or mild risk on the DSI-SS survey.
  • Have a depression survey score (PHQ-8) of at least 8 before the first visit and a pleasure survey score (SHAPS) above 33 at the first visit.
  • Have major depressive disorder confirmed by a study interview.

Who can't join

  • Currently getting treatment for ADHD.
  • Have a brain or nerve condition, such as epilepsy, seizures other than childhood fever seizures, dementia, stroke, Parkinson’s disease, multiple sclerosis, a brain tumor, or a bulging brain blood vessel. Prior brain surgery or a traumatic brain injury also rules you out.
  • Have an illness or treatment that could interfere with taking part, such as unstable heart disease, HIV/AIDS, cancer, or liver or kidney problems.
  • Have a brain device or implant, a heart pacemaker, or any other implanted electronic device.
  • Be pregnant or have claustrophobia, a fear of closed spaces.
  • Have a current moderate or severe drug or alcohol use disorder, a past severe drug or alcohol use disorder, or a psychotic disorder within the past 12 months.
  • Have iron-containing metal in your body, face or neck tattoos, work as a metal worker, or have an eye injury involving metal. MRI rules also require removing jewelry and avoiding clothing with metal, including underwire or activewear that may contain tiny metal particles.
  • Have any other issue that the study doctor thinks could increase your risk or keep you from following or finishing the study.

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

Official eligibility criteria

Inclusion Criteria: * Between the ages of 18 and 65 * Able to provide informed consent * Have normal to corrected vision * Willing to comply with all study procedures and be available for the duration of the study * Speak and understand English * Mild suicide risk as determined by the Hamilton Depression Rating Scale (HAM-D; less than 3 for the suicidality item) and non-existent or mild risk according to the Depression Symptom Index Suicidality Subscale (DSI-SS). * Patient Health Questionnaire (PHQ-8) greater than or equal to 8 prior to the first session * Snaith Hamilton Pleasure Scale (SHAPS) greater than 33 at the first session * A diagnosis of major depressive disorder on the Mini International Neuropsychiatric Interview for the DSM-V (MINI) Exclusion Criteria: * ADHD (currently under treatment) * Neurological disorders and conditions including, but not limited to history of epilepsy; seizures, except childhood febrile seizures; dementia; history of stroke; Parkinson's disease, multiple sclerosis, cerebral aneurysm; brain tumors * Medical or neurological illness or treatment for a medical disorder that could interfere with study participation. For example, unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment * Prior brain surgery * Any brain devices/implants including cochlear implants and aneurysm clips, cardiac pacemaker, or any other implanted electronic device * History of current traumatic brain injury * Pregnancy (for females) * Current severe substance use disorder * Claustrophobia * Based on the use of MRI, additional exclusion/inclusion criteria are considered. Note that many contraindications for stimulation are common with MRI and thus are not repeated. Participants must not have metal in the body that is ferrous, will be required to remove all jewelry, must not have tattoos on the face or neck, must refrain from wearing metal in clothing (underwire) or active gear (possibility of metallic microparticle technology), must not be a metal worker or have an eye injury involving metal. * Anything that in the opinion of the investigator would place the participant at increased risk or preclude the participant's full compliance with or completion of the study * DSM-V diagnosis of present moderate or severe substance use disorder or alcohol use disorder, and past severe substance use disorder or alcohol use disorder, or psychotic disorder within the last 12 months

Study sites (1)

FL