- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03433339
Spinal Cord Stimulation for the Treatment of Major Depressive Disorder (SPIDEP)
March 29, 2024 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
Detailed 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.
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
-
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Ohio
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Mason, Ohio, United States, 45040
- Lindner Center of HOPE/University of Cincinnati
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-
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
Description
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.
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 |
---|---|
Sham Comparator: Sham Treatment
Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks.
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Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
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Experimental: Active Treatment
Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks.
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Active 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 |
---|---|---|
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.
|
8 weeks (or last available observation).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Skin Redness
Time Frame: 8 weeks
|
Number of participants with skin redness in the active and sham tsDCS groups.
|
8 weeks
|
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.
|
8 weeks
|
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.
|
8 weeks
|
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.
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8 weeks
|
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.
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8 weeks
|
Binge Eating Scale (BES) Score Change
Time Frame: 8 weeks
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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
|
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 weeks
|
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.
|
8 weeks
|
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.
|
8 weeks
|
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.
|
8 weeks
|
Adiponectin Level Change
Time Frame: 8 weeks
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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.
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8 weeks
|
Leptin Level Change
Time Frame: 8 weeks
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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.
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8 weeks
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Cortisol Level Change
Time Frame: 8 weeks
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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.
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8 weeks
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Insulin Level Change
Time Frame: 8 weeks
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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.
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8 weeks
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Fibroblast Growth Factor-21 (FGF-21) Level Change
Time Frame: 8 weeks
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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
|
Fatty Acid (LCn-3) Level Change
Time Frame: 8 weeks
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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.
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8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotion Recognition Task Scores Change (Exploratory)
Time Frame: 8 weeks
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Emotion recognition task scores change from baseline to week 8 (or last available observation)
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8 weeks
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Stop Signal Task Scores Change (Exploratory)
Time Frame: 8 weeks
|
Stop signal task scores change from baseline to week 8 (or last available observation)
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 23, 2024
Last Update Submitted That Met QC Criteria
March 29, 2024
Last Verified
March 1, 2024
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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