NCT05617495 Mindfulness-Based fMRI Neurofeedback for Depression
| NCT ID | NCT05617495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Depression in Adolescence |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-04-10 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-04-10 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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-old * Written informed assent/consent and parental/guardian permission for 13-17 year-olds or informed consent for 18 year-olds * Tanner puberty stage ≥3 * Meets current diagnostic criteria for MDD * English fluency Exclusion 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 disorders * Substance use disorder, moderate or severe in past 6 months * Active suicidal ideation with a specific plan * History of seizure disorder * Medical or neurological illness (e.g., severe head injury) * MRI contraindications * Current psychotropic medication use other than antidepressant medication * Intelligence quotient (IQ) \<80.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05617495 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying Depression in Adolescence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05617495 currently recruiting?
Yes, NCT05617495 is actively recruiting participants. Contact the research team at rpa2009@cumc.columbia.edu for enrollment information.
Where is the NCT05617495 trial being conducted?
This trial is being conducted at Boston, United States, New York, United States.
Who is sponsoring the NCT05617495 clinical trial?
NCT05617495 is sponsored by Columbia University. The trial plans to enroll 90 participants.
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