Amygdala Neurofeedback for Depression - Large Scale Clinical Trial
Recruiting · NCT05703256 · Interventional (participants receive a specific treatment) · Lead sponsor: Kymberly Young
View the official record on ClinicalTrials.gov →Interventions studied
Amygdala real-time fMRI neurofeedbackSham feedback
What this trial is about
The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as a stand-alone intervention for major depressive disorder
Who can take part
Age range
18 Years to 55 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
- ages 18 - 55
- primary diagnosis of MDD and are currently depressed
- able to give written informed consent prior to participation
- unmedicated OR are stable on an antidepressant regime (at least 4 weeks to ensure symptoms are stable). Effective medications will not be discontinued for the purposes of the study.
Exclusion criteria
- clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
- Current severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild or moderate alcohol or substance use would also interfere with the effects of the intervention.
- history of traumatic brain injury
- unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
- currently pregnant or breast feeding
- unable to complete questionnaires written in English
- current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study.
- diagnosis of psychotic or organic mental disorder, bipolar I or II disorder.
- eye problems or difficulties in corrected vision.
Where it is running
1 location listed across 1 US state.
- University of Pittsburgh - Pittsburgh, Pennsylvania, United States