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Depression Neuromodulation trials

Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains

RecruitingNCT06795451Phase: PHASE1, PHASE2Started 2025-02-25

Summary

Spinal interoceptive pathways (SIPs) convey bodily signals to an interoceptive system in the brain and their dysregulation is linked to major depressive disorder (MDD). Current treatments are partially effective and the role of SIPs in MDD is vastly unexplored. Preliminary data suggests that SIPs are feasible therapeutic targets in MDD. The central hypothesis is that non-invasive spinal cord stimulation will modulate SIPs to elucidate their role and therapeutic potential in MDD using an R61/33 p

Eligibility

Sex
ALL
Min Age
18 Years
Max Age
60 Years

Inclusion Criteria: * 18 to 60 yrs., inclusive, * Female or Male, * With current MDD episode according to MINI 7.0.2. duration (≥4 weeks and ≤ 2 yrs.), * Current BMI ≥18.5 and ≤ 35.99 kg/mts2 * MADRS score at screening ≥18 * Currently on an FDA- approved antidepressant medication at a stable the

Locations

Lindner Center of Hope
Mason, Ohio, United States

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