Spinal Cord Stimulation for the Treatment of Major Depressive Disorder (SPIDEP)

University of Cincinnati

Status and phase: Completed; Phase 2; Phase 1

Conditions: Major Depressive Disorder

Treatments: Device: Sham transcutaneous spinal direct current stimulation; Device: Active transcutaneous spinal direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03433339

SPIDEP 2017-7424

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Active Treatment

Experimental group

Description:

Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks.

Treatment:

Device: Active transcutaneous spinal direct current stimulation

Sham Treatment

Sham Comparator group

Description:

Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks.

Treatment:

Device: Sham transcutaneous spinal direct current stimulation