Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression
Recruiting · NCT06132581 · Interventional (participants receive a specific treatment) · Lead sponsor: Florida State University
View the official record on ClinicalTrials.gov →Interventions studied
Delta-beta tACS via the Neurocare Direct Current Stimulator Multi-Channel 4Sham tACS via the Neurocare Direct Current Stimulator Multi-Channel 4Theta-gamma tACS via the Neurocare Direct Current Stimulator Multi-Channel 4
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Florida State University - Tallahassee, Florida, United States