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NCT05617495
Mindfulness-Based fMRI Neurofeedback for Depression
Conditions: Depression in Adolescence, Rumination
Sex: All
Ages: 13 Years – 18 Years
Phase: NA
Enrollment: 90
Sponsor: Columbia University
Summary
In the United States, adolescents experience alarmingly high rates of major depression, and gold-standard treatments are only effective for approximately half of patients.
Rumination may be a promising treatment target, as it is well-characterized at the neural level and contributes to depression onset, maintenance, and recurrence as well as predicts treatment non-response.
Accordingly, the proposed research will investigate whether an innovative mindfulness-based real-time functional magnetic resonance imaging (fMRI) neurofeedback intervention successfully elicits change in the brain circuit underlying rumination to improve clinical outcomes among depressed adolescents.
Eligibility Criteria
Inclusion Criteria:Ages 13-18 years-oldWritten informed assent/consent; parental/guardian permission for 13-17 year-olds or consent for 18 year-oldsTanner puberty stage ≥3Current diagnostic criteria for MDDEnglish fluencyExclusion Criteria:Lifetime history of primary psychotic disorders, bipolar disorder, oppositional defiant disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or eating disordersSubstance use disorder, moderate or severe in past 6 monthsActive suicidal ideation with a specific planHistory of seizure disorderMedical or neurological illness (e.g., head injury, loss of consciousness >5 minutes)MRI contraindicationsCurrent psychotropic medication use other than antidepressant medicationIntelligence quotient (IQ) <80.
Source: ClinicalTrials.gov (NCT05617495). StuddyBuddy aggregates publicly available trial information.