Status:
COMPLETED
Spinal Cord Stimulation for the Treatment of Major Depressive Disorder
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Lindner Center of HOPE
Brain & Behavior Research Foundation
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct current stimulation (tsDCS) in major depressive disorder.
Detailed Description
This study aims to 1) determine the efficacy and safety of tsDCS in adult patients with major depressive disorder (MDD) and 2) investigate interoceptive awareness, somatic symptoms, autonomic and meta...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- age 18-55 yrs., inclusive
- female or male
- Body mass index (BMI) 18.5 to 35 kg/mts2, inclusive
- current MDD episode diagnoses confirmed by Mini International Neuropsychiatric Interview (MINI) 5.0 with a duration of ≥1 month and ≤24 months
- moderate MDD symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20 to ≤35
- no current or recent (past month) antidepressant pharmacological treatment
- Generalized anxiety disorder (GAD) and other anxiety symptoms will be permitted
- using an effective contraceptive method (all participants of childbearing potential).
- Exclusion criteria:
- Current or lifetime MDD episode non-responsive to two or more antidepressant treatments at adequate doses and time (including ECT)
- Current or lifetime bipolar disorder or schizophrenia diagnosis
- current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed)
- significant risk of suicide according to Columbia Suicide Severity Rating Scale (CSSRS) or clinical judgment, or suicidal behavior in the past year
- current chronic severe pain conditions
- current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month)
- neurological, endocrinological, cardiovascular (including diagnosed hypertension) or other clinically significant medical conditions as judged by the clinician
- skin lesions on electrode placement region
- implanted electrical medical devices
- Pregnancy
- suspected Intellectual quotient (IQ)\<80
- any other clinically relevant reason as judged by the clinician.
Exclusion
Key Trial Info
Start Date :
August 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03433339
Start Date
August 29 2018
End Date
September 13 2022
Last Update
December 27 2024
Active Locations (1)
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1
Lindner Center of HOPE/University of Cincinnati
Mason, Ohio, United States, 45040