RECRUITING

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

Conditions

Major Depressive Disorder Anhedonia Transcranial alternating current stimulation Goal-directed behavior Cross-frequency coupling

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-24

Study Completion:2026-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06132581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Justin M Riddle, PhD

CONTACT

850-645-2389

jriddle@fsu.edu

Study Locations (Sites)

Florida State University

Tallahassee, Florida, 32306

United States

Collaborators and Investigators

Sponsor: Florida State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-24

Study Completion Date2026-07-31

Study Record Updates

Study Start Date2024-01-24

Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

Transcranial alternating current stimulation
Goal-directed behavior
Cross-frequency coupling

Additional Relevant MeSH Terms

Major Depressive Disorder
Anhedonia