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

October 10, 2022 updated by: Francisco Romo-Nava, University of Cincinnati
This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct current stimulation (tsDCS) in major depressive disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Mason, Ohio, United States, 45040
        • Lindner Center of HOPE/University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MADRS score change
Time Frame: 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.
8 weeks (or last available observation).

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion recognition task scores change (exploratory)
Time Frame: 8 weeks
Emotion recognition task scores change from baseline to week 8 (or last available observation)
8 weeks
Stop signal task scores change (exploratory)
Time Frame: 8 weeks
Stop signal task scores change from baseline to week 8 (or last available observation)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

Lindner Center of HOPE
Brain & Behavior Research Foundation

Investigators

  • Principal Investigator: Francisco Romo-Nava, MD,PhD, University of Cincinnati/ Lindner Center of HOPE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2018

Primary Completion (Actual)

September 13, 2022

Study Completion (Actual)

September 13, 2022

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPIDEP 2017-7424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

A plan for individual participant data is not included in the current protocol. Following Federal, State and Institutional regulations, data could be shared with other researchers after the study ends.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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