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

Launched by UNIVERSITY OF CINCINNATI · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with Major Depressive Disorder (MDD) by exploring the role of spinal interoceptive pathways (SIPs), which are responsible for sending signals from the body to the brain. Researchers believe that these pathways might be important in understanding and treating depression. The trial will use a method called transcutaneous spinal direct current stimulation (tsDCS), which is a non-invasive technique that aims to activate these pathways and help improve symptoms of depression. The team will measure changes in brain activity to see if the treatment is effective.

To participate in this study, individuals must be between 18 and 60 years old and currently experiencing an episode of depression that has lasted at least four weeks. They should also be on a stable dose of an approved antidepressant medication. Participants should not have certain other mental health conditions, severe neurological issues, or any significant medical problems. If eligible, participants can expect to take part in a double-blind study, meaning neither they nor the researchers will know who is receiving the active treatment versus a placebo (a treatment without active ingredients). This approach helps ensure the results are reliable. The trial is currently recruiting, and those interested should consult their healthcare provider for more details.

Gender

ALL

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 kg/mts2, inclusive,
• • MADRS score at screening ≥18
• • Currently on an FDA- approved antidepressant medication at a stable therapeutic dose for ≥ 8 weeks,
• • Psychotherapeutic interventions are allowed if dose/frequency stable for ≥4 weeks,
• • Anxiety disorders allowed if no more than moderate in severity and are not the main diagnosis,
• • Using an effective contraceptive method (participants with childbearing potential), and 10)Able to complete study related tasks.
• Exclusion Criteria:
• • Treatment resistance during current depressive episode (\>2 treatment trials at adequate doses/duration), including medication and neuromodulation treatments.
• • Current/lifetime diagnosis of bipolar disorder or schizophrenia spectrum disorders.
• • Significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year.
• • Psychotic symptoms during the current MDD episode or in the past 6 months.
• • Current (past month) substance use disorder (nicotine, caffeine allowed).
• • Current unstable neurological conditions including seizure disorders (infantile seizures are not exclusionary), neurodegenerative disorders, or stroke.
• • Evidence of severe peripheral neuropathy.
• • History of moderate to severe traumatic brain injury (e.g., skull fracture or loss of consciousness \>10 minutes) or spinal cord injury.
• • Unstable clinically significant medical conditions (e.g., uncontrolled hypertension as indicated by a systolic \>150 mmHg or diastolic \>95mmHg).
• • History of cancer allowed if remitted for the past 5 years.
• • Use of anticonvulsant medications and calcium channel blockers at screening.
• • Current severe pain conditions or need for chronic use of pain medication including NSAIDs and opiates.
• • Implanted electronic medical devices.
• • Neuromodulation interventions in the past month.
• • Active skin lesions on electrode placement sites.
• • pregnant or breastfeeding.
• • Suspected IQ \<80.
• • Any other relevant clinical reason as judged by the clinician.