Targeting Spinal Pathways for Major Depression

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

Recruiting Phase 1 Phase 2 Interventional Study
Depression - Major Depressive Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
67 (estimated)
Sponsor
University of Cincinnati · Other
Who this trial is looking for

This trial is looking for adults with major depressive disorder to test a new way to help manage their symptoms using a method called spinal cord stimulation. Participants will undergo treatments and complete assessments to see how well the method works.

Are You a Good Fit for This Trial?
Must be taking Antidepressant medication

You may be able to join if

  • I am between 18 and 60 years old.
  • I have a current episode of major depressive disorder lasting more than 4 weeks.
  • I have a body mass index (BMI) between 18.5 and 35.99.
  • I have a score of 18 or higher on the MADRS at screening.
  • I have been on a stable dose of an FDA-approved antidepressant for at least 8 weeks.
  • I can use effective contraception if I can get pregnant.
  • I am able to complete study-related tasks.

You may not be able to join if

  • I have not responded to more than two treatment trials for my depression.
  • I have a current or past diagnosis of bipolar disorder or schizophrenia.
  • I have had significant suicidal thoughts or behaviors in the past year.
  • I currently have a substance use disorder.
  • I have unstable neurological conditions, such as seizure disorders.
  • I have a history of severe traumatic brain injury or spinal cord injury.
  • I have unstable medical conditions like uncontrolled high blood pressure.
  • I am pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 stimu…
Trial Locations
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Eligibility Criteria
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…
Contacts

Georgi Georgiev

513-536-0731

georgi.georgiev@lindnercenter.org

CONTACT