Trial Outcomes & Findings for Spinal Cord Stimulation for the Treatment of Major Depressive Disorder (NCT NCT03433339)

NCT ID: NCT03433339

Last Updated: 2024-12-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 8 weeks (or last available observation).
• Results posted on: 2024-12-27

Participant Flow

All study procedures involving participants were conducted at the Lindner Center of HOPE (affiliated with the University of Cincinnati) in Mason, Ohio, with a recruitment period from August 29, 2018, to September 13, 2022.

Pre-screened 671 participants. Forty two were assessed for eligibility on site. A total of 22 were excluded for not meeting eligibility criteria (n=19) or declined to participate (n=3). A total of 20 participants were randomized.

Participant milestones

Measure	Active Treatment Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Overall Study STARTED	10	10
Overall Study COMPLETED	8	6
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	Active Treatment Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Overall Study Lost to Follow-up	2	0
Overall Study Coronavirus disease (COVID-19) Pandemic Related Restrictions	0	2
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

Baseline characteristics by cohort

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Total n=19 Participants Total of all reporting groups
Age, Continuous	31.6 years STANDARD_DEVIATION 9.8 • n=5 Participants	36.8 years STANDARD_DEVIATION 13.1 • n=7 Participants	34.2 years STANDARD_DEVIATION 11.45 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Montgomery Asberg Depression Rating Scale (MADRS) Score	29.0 summed total scores STANDARD_DEVIATION 2.3 • n=5 Participants	29.4 summed total scores STANDARD_DEVIATION 3.8 • n=7 Participants	29.2 summed total scores STANDARD_DEVIATION 3.05 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks (or last available observation).

Population: All participants with at least one post baseline Montgomery Asberg Depression Rating Scale total scores assessment were included in the analysis.

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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Montgomery Asberg Depression Rating Scale (MADRS) Score Change	-21.7 summed total scores Standard Error 2.3	-14.6 summed total scores Standard Error 2.5

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Number of Participants With Skin Redness	9 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Clinical Global Impression-Improvement (CGI-I)	1.3 total score of the scale Standard Error 0.3	2.0 total score of the scale Standard Error 0.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change	-3.2 score on a scale Standard Error 0.4	-1.8 score on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Patient Health Questionnaire-9 (PHQ-9) Score Change	-12.6 score on a scale Standard Error 2.2	-10.3 score on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale	-0.0 score on a scale Standard Error 0.5	-0.2 score on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Binge Eating Scale (BES) Score Change	-7.3 score on a scale Standard Error 2.7	-3.0 score on a scale Standard Error 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Four-Dimensional Symptom Questionnaire (4-DSQ)- Somatization Dimension Score Change	-3.3 score on a scale Standard Error 2.1	-6.9 score on a scale Standard Error 2.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Systolic Blood Pressure Score Change	-5.0 mmHg Standard Error 3.9	-2.9 mmHg Standard Error 4.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Heart Rate Score Change	4.7 Beats per minute Standard Error 3.9	5.3 Beats per minute Standard Error 4.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Body Mass Index Change	-0.3 kg/m^2 Standard Error 2.0	1.5 kg/m^2 Standard Error 2.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Adiponectin Level Change	-805 ug/mL Standard Error 1640	1472 ug/mL Standard Error 2409

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Leptin Level Change	-1.5 ng/mL Standard Error 4.4	2.7 ng/mL Standard Error 6.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Cortisol Level Change	-0.7 nmol/L Standard Error 2.2	-0.9 nmol/L Standard Error 3.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Insulin Level Change	-4.2 Milli-international Units/ Liter (mIU/L) Standard Error 4.6	-7.2 Milli-international Units/ Liter (mIU/L) Standard Error 6.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Fibroblast Growth Factor-21 (FGF-21) Level Change	-13.3 ng/ml Standard Error 53.2	-30.9 ng/ml Standard Error 78.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Treatment n=10 Participants Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 Participants Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Fatty Acid (LCn-3) Level Change	-0.02 Percentage change Standard Error 0.19	-0.01 Percentage change Standard Error 0.22

Adverse Events

Active Treatment

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Sham Treatment

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active Treatment n=10 participants at risk Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks. Active transcutaneous spinal direct current stimulation: Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.	Sham Treatment n=9 participants at risk Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Sham transcutaneous spinal direct current stimulation: Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Nervous system disorders Anxiety/Panic symptoms	10.0% 1/10 • Number of events 1 • During the eight week study duration.	11.1% 1/9 • Number of events 1 • During the eight week study duration.
Cardiac disorders Asymptomatic decrease in heart rate	10.0% 1/10 • Number of events 1 • During the eight week study duration.	0.00% 0/9 • During the eight week study duration.
Skin and subcutaneous tissue disorders Itching/Burnign sensation	60.0% 6/10 • Number of events 6 • During the eight week study duration.	44.4% 4/9 • Number of events 4 • During the eight week study duration.
Respiratory, thoracic and mediastinal disorders Cold-like symptoms	20.0% 2/10 • Number of events 2 • During the eight week study duration.	0.00% 0/9 • During the eight week study duration.
Respiratory, thoracic and mediastinal disorders COVID-19	10.0% 1/10 • Number of events 1 • During the eight week study duration.	0.00% 0/9 • During the eight week study duration.
Skin and subcutaneous tissue disorders Dermatitis	20.0% 2/10 • Number of events 2 • During the eight week study duration.	0.00% 0/9 • During the eight week study duration.
Infections and infestations External Ear Infection	10.0% 1/10 • Number of events 1 • During the eight week study duration.	0.00% 0/9 • During the eight week study duration.
Skin and subcutaneous tissue disorders Friction Blister in Feet	0.00% 0/10 • During the eight week study duration.	11.1% 1/9 • Number of events 1 • During the eight week study duration.
Infections and infestations Gastroenteritis	0.00% 0/10 • During the eight week study duration.	11.1% 1/9 • Number of events 1 • During the eight week study duration.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • During the eight week study duration.	33.3% 3/9 • Number of events 3 • During the eight week study duration.
Respiratory, thoracic and mediastinal disorders Pharyngitis	0.00% 0/10 • During the eight week study duration.	11.1% 1/9 • Number of events 1 • During the eight week study duration.
Nervous system disorders Prickling Sensation	10.0% 1/10 • Number of events 1 • During the eight week study duration.	11.1% 1/9 • Number of events 1 • During the eight week study duration.
Skin and subcutaneous tissue disorders Rash	10.0% 1/10 • Number of events 1 • During the eight week study duration.	11.1% 1/9 • Number of events 1 • During the eight week study duration.
Skin and subcutaneous tissue disorders Skin abrasion	0.00% 0/10 • During the eight week study duration.	11.1% 1/9 • Number of events 1 • During the eight week study duration.
Skin and subcutaneous tissue disorders Skin redness	90.0% 9/10 • Number of events 9 • During the eight week study duration.	44.4% 4/9 • Number of events 4 • During the eight week study duration.
Reproductive system and breast disorders Vaginities	10.0% 1/10 • Number of events 1 • During the eight week study duration.	0.00% 0/9 • During the eight week study duration.

Additional Information

Dr. Francisco Romo-Nava

Lindner Center of HOPE/ University of Cincinnati Department of Psychiatry and Behavioral Neurosciences

Phone: 513-536-0725

Email: romofo@ucmail.uc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place