Phase 2 N=20 Randomized Quadruple-blind Treatment

Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03433339 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcome: Primary: Montgomery Asberg Depression Rating Scale (MADRS) Score Change — -21.7; -14.6 summed total scores — p==0.040

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Active transcutaneous spinal direct current stimulation (Device); Sham transcutaneous spinal direct current stimulation (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Cincinnati
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Montgomery Asberg Depression Rating Scale (MADRS) Score Change	-21.7; -14.6	=0.040 sig
SECONDARY Number of Participants With Skin Redness	9; 4	—
SECONDARY Clinical Global Impression-Improvement (CGI-I)	1.3; 2.0	—
SECONDARY Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change	-3.2; -1.8	—
SECONDARY Patient Health Questionnaire-9 (PHQ-9) Score Change	-12.6; -10.3	—
SECONDARY Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale	-0.0; -0.2	—
SECONDARY Binge Eating Scale (BES) Score Change	-7.3; -3.0	—
SECONDARY Four-Dimensional Symptom Questionnaire (4-DSQ)- Somatization Dimension Score Change	-3.3; -6.9	—
SECONDARY Systolic Blood Pressure Score Change	-5.0; -2.9	—
SECONDARY Heart Rate Score Change	4.7; 5.3	—
SECONDARY Body Mass Index Change	-0.3; 1.5	—
SECONDARY Adiponectin Level Change	-805; 1472	—
SECONDARY Leptin Level Change	-1.5; 2.7	—
SECONDARY Cortisol Level Change	-0.7; -0.9	—
SECONDARY Insulin Level Change	-4.2; -7.2	—
SECONDARY Fibroblast Growth Factor-21 (FGF-21) Level Change	-13.3; -30.9	—
SECONDARY Fatty Acid (LCn-3) Level Change	-0.02; -0.01	—

Summary

This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct current stimulation (tsDCS) in major depressive disorder.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03433339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.