Clinical trial NCT03433339: Spinal Cord Stimulation for the Treatment of Major Depressive Disorder
Official title: Spinal Cord Stimulation for the Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Keywords: depression
transcutaneous spinal direct current stimulation
non-invasive
major depressive disorder
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Lindner Center of HOPE
name: Brain & Behavior Research Foundation
First posted: 2018-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. age 18-55 yrs., inclusive
2. female or male
3. Body mass index (BMI) 18.5 to 35 kg/mts2, inclusive
4. current MDD episode diagnoses confirmed by Mini International Neuropsychiatric Interview (MINI) 5.0 with a duration of ≥1 month and ≤24 months
5. moderate MDD symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20 to ≤35
6. no current or recent (past month) antidepressant pharmacological treatment
7. Generalized anxiety disorder (GAD) and other anxiety symptoms will be permitted
8. using an effective contraceptive method (all participants of childbearing potential).

Exclusion criteria:

1. Current or lifetime MDD episode non-responsive to two or more antidepressant treatments at adequate doses and time (including ECT)
2. Current or lifetime bipolar disorder or schizophrenia diagnosis
3. current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed)
4. significant risk of suicide according to Columbia Suicide Severity Rating Scale (CSSRS) or clinical judgment, or suicidal behavior in the past year
5. current chronic severe pain conditions
6. 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)
7. neurological, endocrinological, cardiovascular (including diagnosed hypertension) or other clinically significant medical conditions as judged by the clinician
8. skin lesions on electrode placement region
9. implanted electrical medical devices
10. Pregnancy
11. suspected Intellectual quotient (IQ)\<80
12. any other clinically relevant reason as judged by the clinician.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS) Score Change
timeFrame: 8 weeks (or last available observation).
Secondary outcomes:
measure: Number of Participants With Skin Redness
timeFrame: 8 weeks
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: 8 weeks
measure: Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change
timeFrame: 8 weeks
measure: Patient Health Questionnaire-9 (PHQ-9) Score Change
timeFrame: 8 weeks
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale
timeFrame: 8 weeks
measure: Binge Eating Scale (BES) Score Change
timeFrame: 8 weeks
measure: Four-Dimensional Symptom Questionnaire (4-DSQ)- Somatization Dimension Score Change
timeFrame: 8 weeks
measure: Systolic Blood Pressure Score Change
timeFrame: 8 weeks
measure: Heart Rate Score Change
timeFrame: 8 weeks
measure: Body Mass Index Change
timeFrame: 8 weeks
measure: Adiponectin Level Change
timeFrame: 8 weeks
measure: Leptin Level Change
timeFrame: 8 weeks
measure: Cortisol Level Change
timeFrame: 8 weeks
measure: Insulin Level Change
timeFrame: 8 weeks
measure: Fibroblast Growth Factor-21 (FGF-21) Level Change
timeFrame: 8 weeks
measure: Fatty Acid (LCn-3) Level Change
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mason
country: United States
facility: Lindner Center of HOPE/University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati/ Lindner Center of HOPE
name: Francisco Romo-Nava, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: