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

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ClinicalTrials.gov Identifier: NCT03433339
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Lindner Center of HOPE
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Francisco Romo-Nava, University of Cincinnati

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: 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : August 29, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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: transcutaneous spinal direct current stimulation
Anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.

Sham Comparator: Sham Treatment
Thoracic anodal transcutaneous spinal direct current stimulation during a few seconds at the beginning and end of stimulation session of 20min/ three times per week for 8 weeks.
Device: transcutaneous spinal direct current stimulation
Anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Adverse Event frequency difference [ Time Frame: 8 weeks ]
    Differences in adverse event frequency between active and sham tsDCS groups

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433339


Contacts
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Contact: Brian Martens, LSW, MS 513-536-0707 Brian.Martens@LindnerCenter.org
Contact: Georgi Georgiev, MSW 513-536-0707

Locations
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United States, Ohio
Lindner Center of HOPE/University of Cincinnati Recruiting
Mason, Ohio, United States, 45040
Contact: Brian L. Martens    513-536-0707    Brian.Martens@LindnerCenter.org   
Sponsors and Collaborators
University of Cincinnati
Lindner Center of HOPE
Brain & Behavior Research Foundation
Investigators
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Principal Investigator: Francisco Romo-Nava, MD,PhD University of Cincinnati/ Lindner Center of HOPE

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Responsible Party: Francisco Romo-Nava, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03433339     History of Changes
Other Study ID Numbers: SPIDEP 2017-7424
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Francisco Romo-Nava, University of Cincinnati:
depression
transcutaneous spinal direct current stimulation
non-invasive
major depressive disorder

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms