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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03433339
Other study ID # SPIDEP 2017-7424
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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