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Completed

NCT Number: NCT03433339

Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

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

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Lindner Center of HOPE/University of Cincinnati

Mason, Ohio, 45040, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-55 yrs., inclusive
  • female or male
  • Body mass index (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
  • Generalized anxiety disorder (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 Columbia Suicide Severity Rating Scale (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 Intellectual quotient (IQ)<80
  • any other clinically relevant reason as judged by the clinician.

Treatment and study plan

Active transcutaneous spinal direct current stimulation

Device

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

Sham transcutaneous spinal direct current stimulation

Device

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

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale (MADRS) Score Change

    Time frame: 8 weeks (or last available observation).

    Difference in change from baseline to week 8 (or last available observation) in Montgomery Asberg Depression Rating Scale summed total scores scores between active and sham transcutaneous spinal direct current stimulation (tsDCS) groups. Scores range from 0 to 60, with higher scores indicating worse depressive symptom severity.

Secondary outcomes

  1. Number of Participants With Skin Redness

    Time frame: 8 weeks

    Number of participants with skin redness in the active and sham tsDCS groups.

  2. Clinical Global Impression-Improvement (CGI-I)

    Time frame: 8 weeks

    Clinical Global Impression-Improvement (CGI-I) scale score at week 8 (or last available information) difference between Active and Sham tsDCS groups. Range is from 1 to 7 with lower scores indicating better outcome.

  3. Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change

    Time frame: 8 weeks

    MADRS Item 2 score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. MADRS Item 2 (Reported sadness) scores range from 0 to 6 and a higher score indicates a worse severity.

  4. Patient Health Questionnaire-9 (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. Scores range from 0 to 27, with higher scores indicating worse severity.

  5. Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale

    Time frame: 8 weeks

    MAIA Noticing subscale score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Noticing Subscale scores range 0 to 5 and higher scores indicate better outcomes.

  6. 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. Scores range from 0 to 46, with higher scores indicating a worse outcome.

  7. Four-Dimensional Symptom Questionnaire (4-DSQ)- Somatization Dimension Score Change

    Time frame: 8 weeks

    4-DSQ Somatization dimension score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Somatization scale scores range from 0 to 32, with higher scores indicating a worse outcome.

  8. Systolic Blood Pressure Score Change

    Time frame: 8 weeks

    Systolic Blood Pressure score change in mmHg from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Normal range is considered below 140 mmHg. A greater decrease from baseline to week 8 in mmHg is considered favorable.

  9. Heart Rate Score Change

    Time frame: 8 weeks

    Heart Rate score change in beats per minute (BPM) from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Normal BPM is considered between 60 to 100. A decrease in value is considered favorable.

  10. Body Mass Index Change

    Time frame: 8 weeks

    Body mass index (BMI) change in kg/mts2 from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Normal range is 18 to 25 kg/mt2. A decrease in value is considered favorable.

  11. Adiponectin Level Change

    Time frame: 8 weeks

    Adiponectin level change (in ug/mL) from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. No normative levels available. Decreased levels are considered favorable in the context of the study.

  12. Leptin Level Change

    Time frame: 8 weeks

    Leptin level (in ng/ml) change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Usual normal range 4.7 - 23.7 ng/ML. Decreased levels are considered favorable.

  13. 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. Typical afternoon levels may range 5-10 nmol/L. Decreased levels are considered favorable outcomes.

  14. Insulin Level Change

    Time frame: 8 weeks

    Insulin level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Fasting range typically 16-166 Milli-international Units Per Liter (mIU/L). Decreased levels are considered a favorable outcome.

  15. Fibroblast Growth Factor-21 (FGF-21) Level Change

    Time frame: 8 weeks

    Fibroblast growth factor-21 (FGF-21) level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Levels in ng/ml. No normative range established. Decreased levels are considered favorable in the context of the study.

  16. Fatty Acid (LCn-3) Level Change

    Time frame: 8 weeks

    Fatty Acid (LCn-3) level percentage change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Results reported on Erythrocyte eicosapentaenoic acid + docosahexaenoic acid (EPA+DHA) percentage change. Increase in EPA+DHA would indicate a better outcome.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Brain & Behavior Research Foundation
  • Lindner Center of HOPE

Registry information

Acronym: SPIDEP

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2018
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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