SPIDEP: Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

Sponsor

University of Cincinnati (Other)

Overall Status

Recruiting

CT.gov ID

NCT03433339

Collaborator

Lindner Center of HOPE (Other), Brain & Behavior Research Foundation (Other)

Enrollment

Location

Arms

51.1

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Device: Active transcutaneous spinal direct current stimulation Device: Sham transcutaneous spinal direct current stimulation	Phase 1/Phase 2

Detailed Description

This study aims to 1) determine the efficacy and safety of tsDCS in adult patients with 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

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design.8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design.

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 stimulaion protocol assigned to each participant throughout the study.

Primary Purpose:

Treatment

Official Title:

Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

Actual Study Start Date :

Aug 29, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Treatment Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks.	Device: Active transcutaneous spinal direct current stimulation Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Sham Comparator: Sham Treatment Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks.	Device: Sham transcutaneous spinal direct current stimulation Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.

Arm

Intervention/Treatment

Experimental: Active Treatment

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

Device: Active transcutaneous spinal direct current stimulation

Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.

Sham Comparator: Sham Treatment

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

Device: Sham transcutaneous spinal direct current stimulation

Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.

Outcome Measures

Primary Outcome Measures

MADRS score change [8 weeks (or last available observation).]
Difference in change from baseline to week 8 (or last available observation) in MADRS scores between active and sham tsDCS groups.

Secondary Outcome Measures

Adverse Event frequency difference [8 weeks]
Differences in adverse event frequency between active and sham tsDCS groups
Clinical Global Impression-Severity (CGI-S) [8 weeks]
CGI-S change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Clinical Global Impression-Improvement (CGI-I) [8 weeks]
CGI-I change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
MADRS Sub-component score [8 weeks]
MADRS Sub-Component score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
PHQ-9 score change [8 weeks]
PHQ-9 score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Multidimensional Assessment of Interoceptive Awareness (MAIA) score change [8 weeks]
MAIA score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Binge Eating Scale (BES) score change [8 weeks]
BES score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Four-Dimensional Symptom Questionnaire (4-DSQ) score change [8 weeks]
4-DSQ score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Blood Pressure score change [8 weeks]
Blood Pressure score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Heart Rate score change [8 weeks]
Heart Rate score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Body Mass Index change [8 weeks]
BMI change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Waist Circumference change [8 weeks]
Waist Circumference score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Hip Circumference change [8 weeks]
Hip Circumference score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Adiponectin level change [8 weeks]
Adiponectin level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Leptin level change [8 weeks]
Leptin level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Cortisol level change [8 weeks]
Cortisol level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Insulin level change [8 weeks]
Insulinl level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
FGF-21 level change [8 weeks]
FGF-21 level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Fatty Acid (LCn-3) level change [8 weeks]
Fatty Acid (LCn-3) level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.

Other Outcome Measures

Emotion recognition task scores change (exploratory) [8 weeks]
Emotion recognition task scores change from baseline to week 8 (or last available observation)
Stop signal task scores change (exploratory) [8 weeks]
Stop signal task scores change from baseline to week 8 (or last available observation)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

age 18-55 yrs., inclusive
female or male
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
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 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 IQ<80
any other clinically relevant reason as judged by the clinician.