Major Depressive Disorder Clinical Trial
— SPIDEPOfficial title:
Spinal Cord Stimulation for the Treatment of Major Depressive Disorder
Verified date | March 2024 |
Source | University of Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct current stimulation (tsDCS) in major depressive disorder.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Lindner Center of HOPE/University of Cincinnati | Mason | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati | Brain & Behavior Research Foundation, Lindner Center of HOPE |
United States,
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 |
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