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Behavioral Intervention
Amygdala Neurofeedback for Depression
N/A
Recruiting
Led By Kymberly Young, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
must be able to give written informed consent prior to participation
must have a SHAPS score > 4, indicating the presence of anhedonia
Timeline
Screening 2 days
Treatment 2 weeks
Follow Up 3 months
Awards & highlights
Summary
This trial will test whether training patients to increase their amygdala's response to positive memories can help treatment-resistant depression.
Who is the study for?
This trial is for right-handed adults aged 18-55 with Major Depressive Disorder (MDD) who haven't improved after two SSRI treatments. Participants can be unmedicated or on a stable SSRI regimen, must experience anhedonia, and have difficulty recalling specific positive memories. Exclusions include other major psychiatric disorders, recent substance dependence, traumatic brain injury, MRI incompatibility (like claustrophobia), pregnancy, breastfeeding, non-English speakers, vision issues without correction, and certain unstable medical conditions.
What is being tested?
The study tests if neurofeedback using real-time fMRI can help patients with treatment-resistant depression by enhancing the amygdala's response to positive memories. It involves two types of neurofeedback: one targeting the parietal region and another focusing on the amygdala of the brain.
What are the potential side effects?
Since this trial uses neurofeedback through fMRI scanning rather than medication or invasive procedures, side effects are minimal but may include discomfort from staying still during scans or anxiety from being in a confined space like an MRI machine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have anhedonia. This means you are experiencing social withdrawl, you find diminshed pleasure from daily activites, you are less interested in previous hobbies, and you have a loss of libido.
Select...
I am not on antidepressants or have been stable on SSRI antidepressants for at least 3 weeks.
Select...
I have tried two SSRI medications without success.
Timeline
Screening ~ 2 days0 visits
Treatment ~ 2 weeks2 visits
Follow Up ~ 3 months0 visits
Screening ~ 2 days
Treatment ~ 2 weeks
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Beck Depression Inventory (BDI-II)
Secondary study objectives
Amygdala Activity
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Amygdala NeurofeedbackExperimental Treatment1 Intervention
attempt to up regulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Five sessions will be performed within a 2 month period.
Group II: Parietal NeurofeedbackActive Control1 Intervention
attempt to upregulate the left horizontal segment of the intraparietal sulcus, a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback. Five sessions will be performed within a 2 month period.
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,762 Previous Clinical Trials
16,347,903 Total Patients Enrolled
Kymberly Young, PhDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
1 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have an MRI scan due to feeling very uncomfortable in small or enclosed spaces (claustrophobia) or having certain metal objects inside your body.I do not have any serious or unstable health conditions.I have tried two SSRI medications without success.I am not currently taking any medications that affect brain blood flow, except for SSRIs.I am right-handed, aged 18-55, with diagnosed recurrent major depression and currently feeling depressed.I am not on antidepressants or have been stable on SSRI antidepressants for at least 3 weeks.You have eye problems or need corrective lenses to see clearly.I do not have a diagnosis of severe mental disorders like schizophrenia, bipolar disorder, or autism.You have had a head injury in the past.You have anhedonia. This means you are experiencing social withdrawl, you find diminshed pleasure from daily activites, you are less interested in previous hobbies, and you have a loss of libido.
Research Study Groups:
This trial has the following groups:- Group 1: Parietal Neurofeedback
- Group 2: Amygdala Neurofeedback
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 2 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT03428828 — N/A
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