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NCT05703256
Amygdala Neurofeedback for Depression - Large Scale Clinical Trial
Conditions: Major Depressive Disorder
Sex: All
Ages: 18 Years – 55 Years
Phase: NA
Enrollment: 200
Sponsor: University of Pittsburgh
Location: United States
Summary
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
Eligibility Criteria
Inclusion Criteria:ages 18 - 55primary diagnosis of MDD and are currently depressedable to give written informed consent prior to participationunmedicated 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 disorderCurrent 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 injuryunable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)currently pregnant or breast feedingunable to complete questionnaires written in Englishcurrent (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.
Source: ClinicalTrials.gov (NCT05703256). StuddyBuddy aggregates publicly available trial information.