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

Launched by FLORIDA STATE UNIVERSITY · Nov 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a condition called anhedonia, which is the inability to feel pleasure and is often a symptom of major depressive disorder. Researchers want to understand how a specific type of brain stimulation over five consecutive days might help improve goal-directed behavior in people who are experiencing severe depression and have high levels of anhedonia. By focusing on this, the team hopes to find new ways to support individuals who struggle to find joy in activities they once enjoyed.

To participate in this study, individuals must be between 18 and 65 years old and have a diagnosis of major depressive disorder. They should be able to understand and speak English and agree to follow all study procedures. Participants will undergo assessments to ensure they are suitable for the trial, including checks for mild suicide risk. Throughout the study, they can expect to receive brain stimulation and be closely monitored by the research team. It's important to note that certain medical conditions, such as neurological disorders or significant substance use issues, may exclude someone from participating.

Gender

ALL

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