Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— SPIDEP  

Official title:

Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433339
• Other study ID #: SPIDEP 2017-7424
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 29, 2018
• Est. completion date: September 13, 2022

Study information

• Verified date: March 2024
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Active transcutaneous spinal direct current stimulation
Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
• Sham transcutaneous spinal direct current stimulation
Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.

Locations

Country	Name	City	State
United States	Lindner Center of HOPE/University of Cincinnati	Mason	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	Brain & Behavior Research Foundation, Lindner Center of HOPE

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emotion Recognition Task Scores Change (Exploratory)	Emotion recognition task scores change from baseline to week 8 (or last available observation)	8 weeks
Other	Stop Signal Task Scores Change (Exploratory)	Stop signal task scores change from baseline to week 8 (or last available observation)	8 weeks
Primary	Montgomery Asberg Depression Rating Scale (MADRS) Score Change	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.	8 weeks (or last available observation).
Secondary	Number of Participants With Skin Redness	Number of participants with skin redness in the active and sham tsDCS groups.	8 weeks
Secondary	Clinical Global Impression-Improvement (CGI-I)	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.	8 weeks
Secondary	Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change	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.	8 weeks
Secondary	Patient Health Questionnaire-9 (PHQ-9) Score Change	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.	8 weeks
Secondary	Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale	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.	8 weeks
Secondary	Binge Eating Scale (BES) Score Change	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.	8 weeks
Secondary	Four-Dimensional Symptom Questionnaire (4-DSQ)- Somatization Dimension Score Change	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 weeks
Secondary	Systolic Blood Pressure Score Change	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.	8 weeks
Secondary	Heart Rate Score Change	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.	8 weeks
Secondary	Body Mass Index Change	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.	8 weeks
Secondary	Adiponectin Level Change	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.	8 weeks
Secondary	Leptin Level Change	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.	8 weeks
Secondary	Cortisol Level Change	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.	8 weeks
Secondary	Insulin Level Change	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.	8 weeks
Secondary	Fibroblast Growth Factor-21 (FGF-21) Level Change	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.	8 weeks
Secondary	Fatty Acid (LCn-3) Level Change	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.	8 weeks