Spinal Cord Stimulation for the Treatment of Major Depressive Disorder
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Cincinnati
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Montgomery Asberg Depression Rating Scale (MADRS) Score Change
Study Overview
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 metabolic regulation as potential mediators of antidepressant response to tsDCS. We predict that 1) Active tsDCS treatment will result in a greater decrease in depressive symptom severity compared to Sham tsDCS in adult patients with MDD, 2) active tsDCS will be safe and well tolerated in adult patients with MDD and 3) change in interoceptive awareness, somatic symptoms, and autonomic and metabolic parameters will be associated with change in depressive symptom severity. To accomplish these aims, we will conduct an 8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design. A total of 20 adult antidepressant-free MDD patients will be randomized to receive Active (n=10) or Sham (n=10) tsDCS protocols for 8 weeks in a 1:1 ratio. We will combine the use of a tsDCS device, psychometric instruments to diagnose MDD, and measures of depressive symptom severity, somatic symptoms, interoceptive awareness, autonomic function (blood pressure, heart rate), and potential metabolic markers as predictors of response.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
An independent operator (trained personnel from the research team) will prepare the tsDCS device parameters for each session, but will not participate in the rest of the assessments. Patients and raters will remain blinded to spinal stimulation protocol assigned to each participant throughout the study.
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •suspected Intellectual quotient (IQ)<80
- •any other clinically relevant reason as judged by the clinician.
Arms & Interventions
Active Treatment
Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks.
Intervention: Active transcutaneous spinal direct current stimulation (Device)
Sham Treatment
Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks.
Intervention: Sham transcutaneous spinal direct current stimulation (Device)
Outcomes
Primary Outcomes
Montgomery Asberg Depression Rating Scale (MADRS) Score Change
Time Frame: 8 weeks (or last available observation).
Difference in change from baseline to week 8 (or last available observation) in Montgomery Asberg Depression Rating Scale summed total scores scores between active and sham transcutaneous spinal direct current stimulation (tsDCS) groups. Scores range from 0 to 60, with higher scores indicating worse depressive symptom severity.
Secondary Outcomes
- Leptin Level Change(8 weeks)
- Number of Participants With Skin Redness(8 weeks)
- Clinical Global Impression-Improvement (CGI-I)(8 weeks)
- Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change(8 weeks)
- Patient Health Questionnaire-9 (PHQ-9) Score Change(8 weeks)
- Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale(8 weeks)
- Binge Eating Scale (BES) Score Change(8 weeks)
- Four-Dimensional Symptom Questionnaire (4-DSQ)- Somatization Dimension Score Change(8 weeks)
- Heart Rate Score Change(8 weeks)
- Body Mass Index Change(8 weeks)
- Adiponectin Level Change(8 weeks)
- Systolic Blood Pressure Score Change(8 weeks)
- Cortisol Level Change(8 weeks)
- Insulin Level Change(8 weeks)
- Fibroblast Growth Factor-21 (FGF-21) Level Change(8 weeks)
- Fatty Acid (LCn-3) Level Change(8 weeks)
Investigators
Francisco Romo-Nava
Assistant Professor
University of Cincinnati