N/A
N=35
Investigating the Causal Role of Prefrontal Control in Decision-making in Patients With Anhedonia
Major Depressive Disorder · Anhedonia
Bottom Line
View on ClinicalTrials.gov: NCT05084924 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in the Percentage of Trials That the Participant Chooses to Perform the Hard Task — -0.30; -0.22; -0.09 percentage of trials — p=0.049
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cross-frequency transcranial alternating current stimulation via the NeuroConn Direct Current Stimulator Plus (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Percentage of Trials That the Participant Chooses to Perform the Hard Task |
-0.30; -0.22; -0.09 | 0.049 sig |
| SECONDARY Change in Coupling Strength Between Low-frequency Prefrontal Signals and High-frequency Posterior Signals |
0.95; -0.97; 0.13 | 0.004 sig |
Summary
Investigating whether delta-beta cross-frequency transcranial alternating current stimulation can increase goal-directed behavior in participants with major depressive disorder and elevated symptoms of anhedonia.
Eligibility Criteria
Inclusion Criteria
- 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
- Low suicide risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS), and by the Hamilton Depression Rating Scale (HAM-D; less than 3 for the suicidality item).
- Negative pregnancy test for female participants
- Patient Health Questionnaire (PHQ) with 9 items greater than or equal to 10 and a diagnosis of major depressive disorder on the Mini International Neuropsychiatric Interview (MINI)
Exclusion Criteria
- Attention deficit (hyperactivity) disorder (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 (e.g., unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment)
- Prior brain surgery
- Any brain devices/implants, including cochlear implants and aneurysm clips
- History of current traumatic brain injury
- (For females) Pregnant or breast feeding
- 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
- Diagnostic and Statistical Manual of Mental Disorders version 5 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
- Not taking medications for attention deficit (hyperactivity) disorder or benzodiazepines as these medications often produce specific EEG activity that may disrupt our interpretation of the findings
- If major depressive disorder is experienced in episode, the participant must currently be within a depressive episode.
- Contraindications for magnetic resonance imaging (MRI): ferrous metal inside the body, jewelry must be removable, pacemaker or cochlear implant.
Data sourced from ClinicalTrials.gov (NCT05084924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.