Trial Outcomes & Findings for Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder (NCT NCT02329587)

Last Updated: 2018-05-15

Results Overview

The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

Post-treatment (approximately 6.5 weeks post-baseline)

Results posted on

2018-05-15

Participant Flow

A baseline assessment was completed between participant enrollment and randomization. Withdrawal during the baseline assessment could result in enrolled participants not being assigned to a treatment group.

Participant milestones

Participant milestones
Measure	ERP Plus tDCS Exposure and response prevention (ERP) plus anodal transcranial direct current stimulation (tDCS) of right inferior frontal gyrus ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.	ERP Plus Sham tDCS Exposure and response prevention (ERP) plus sham transcranial direct current stimulation (tDCS) of right inferior frontal gyrus ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Baseline Thru Post-treatment Assessment STARTED	5	7
Baseline Thru Post-treatment Assessment Completed All Intervention Sessions	3	4
Baseline Thru Post-treatment Assessment COMPLETED	4	6
Baseline Thru Post-treatment Assessment NOT COMPLETED	1	1
1-month Follow-up STARTED	4	6
1-month Follow-up COMPLETED	4	5
1-month Follow-up NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ERP Plus tDCS n=5 Participants ERP plus anodal tDCS of right inferior frontal gyrus ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.	ERP Plus Sham tDCS n=7 Participants ERP plus sham tDCS of right inferior frontal gyrus ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.	Total n=12 Participants Total of all reporting groups
Age, Continuous	38.00 years STANDARD_DEVIATION 17.42 • n=5 Participants	39.86 years STANDARD_DEVIATION 11.35 • n=7 Participants	39.08 years STANDARD_DEVIATION 13.47 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=7 Participants	0 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	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS): Total Score	24.80 units on a scale STANDARD_DEVIATION 6.50 • n=5 Participants	25.29 units on a scale STANDARD_DEVIATION 4.27 • n=7 Participants	25.08 units on a scale STANDARD_DEVIATION 5.04 • n=5 Participants

PRIMARY outcome

Timeframe: Post-treatment (approximately 6.5 weeks post-baseline)

Population: All participants with available data at the outcome timepoint

The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.

Outcome measures

Outcome measures
Measure	ERP Plus tDCS n=4 Participants ERP plus anodal tDCS of right inferior frontal gyrus ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.	ERP Plus Sham tDCS n=6 Participants ERP plus sham tDCS of right inferior frontal gyrus ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score	15.5 units on a scale Standard Deviation 8.50	16.33 units on a scale Standard Deviation 3.78

PRIMARY outcome

Timeframe: Post-treatment (approximately 6.5 weeks post-baseline)

Population: All participants with available data on outcome measure

The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.

Outcome measures

Outcome measures
Measure	ERP Plus tDCS n=4 Participants ERP plus anodal tDCS of right inferior frontal gyrus ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.	ERP Plus Sham tDCS n=5 Participants ERP plus sham tDCS of right inferior frontal gyrus ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Client Satisfaction Questionnaire-8: Total Score	29.04 units on a scale Standard Deviation 2.76	29.60 units on a scale Standard Deviation 2.51

PRIMARY outcome

Timeframe: Approximately 6.5 weeks post-baseline

Average number of intervention sessions completed

Outcome measures

Outcome measures
Measure	ERP Plus tDCS n=5 Participants ERP plus anodal tDCS of right inferior frontal gyrus ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.	ERP Plus Sham tDCS n=7 Participants ERP plus sham tDCS of right inferior frontal gyrus ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Rates of Session Completion	8.40 Sessions Interval 1.0 to 11.0	8.43 Sessions Interval 1.0 to 11.0

SECONDARY outcome

Timeframe: 1-month follow up (Approximately 11 weeks after baseline assessment)

Population: All available data for participants who completed the 1-month follow-up assesment

The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.

Outcome measures

Outcome measures
Measure	ERP Plus tDCS n=4 Participants ERP plus anodal tDCS of right inferior frontal gyrus ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.	ERP Plus Sham tDCS n=5 Participants ERP plus sham tDCS of right inferior frontal gyrus ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Yale-Brown Obsessive-Compulsive Scale: Total Score	17.25 units on a scale Standard Deviation 8.18	16.20 units on a scale Standard Deviation 5.89

SECONDARY outcome

Timeframe: 1-month follow up (Approximately 11 weeks after baseline assessment)

Population: All available data for participants who completed the 1-month follow-up assessment

The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.

Outcome measures

Outcome measures
Measure	ERP Plus tDCS n=4 Participants ERP plus anodal tDCS of right inferior frontal gyrus ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.	ERP Plus Sham tDCS n=5 Participants ERP plus sham tDCS of right inferior frontal gyrus ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Client Satisfaction Questionnaire-8: Total Score	30.75 units on a scale Standard Deviation 1.26	28.00 units on a scale Standard Deviation 5.05

SECONDARY outcome

Timeframe: Approximately 6.5 weeks post-baseline

Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions.

Outcome measures

Outcome measures
Measure	ERP Plus tDCS n=5 Participants ERP plus anodal tDCS of right inferior frontal gyrus ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.	ERP Plus Sham tDCS n=7 Participants ERP plus sham tDCS of right inferior frontal gyrus ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Rates of Retention in Intervention	3 Participants	4 Participants

Adverse Events

ERP Plus tDCS

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

ERP Plus Sham tDCS

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Sarah Garnaat

Butler Hospital

Phone: 401-455-6659

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	ERP Plus tDCS n=5 participants at risk ERP plus anodal tDCS of right inferior frontal gyrus ERP plus tDCS: Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.	ERP Plus Sham tDCS n=7 participants at risk ERP plus sham tDCS of right inferior frontal gyrus ERP plus sham tDCS: Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Nervous system disorders Trouble sleeping	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	0.00% 0/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Nightmares or other sleep disturbance	80.0% 4/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Feeling drowsy or sleepy	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Feeling nervous or hyper	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Weakness or Fatigue	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Irritable	40.0% 2/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	42.9% 3/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Poor memory	40.0% 2/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Trouble concentrating	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Feeling strange or unreal	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Numbness or tingling	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	0.00% 0/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Dizziness or faintness	40.0% 2/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	42.9% 3/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Headache	40.0% 2/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Blurred vision	40.0% 2/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Ringing in ears or trouble hearing	40.0% 2/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Respiratory, thoracic and mediastinal disorders Stuffy nose	40.0% 2/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	0.00% 0/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Dry mouth	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Muscle twitching or movements	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Trouble sitting still	0.00% 0/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Tremor or shakiness	40.0% 2/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Poor coordination or unsteadiness	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
General disorders Heartbeat rapid or pounding	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
General disorders Trouble catching breath or hyperventilation	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	0.00% 0/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Gastrointestinal disorders Nausea or vomiting	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Gastrointestinal disorders Stomach or abdominal discomfort	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Gastrointestinal disorders Constipation	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Gastrointestinal disorders Diarrhea	60.0% 3/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Loss of sexual interest	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	0.00% 0/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Sweating excessively	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	0.00% 0/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
General disorders Fluid retention or swelling	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	0.00% 0/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Appetite increased	0.00% 0/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Metabolism and nutrition disorders Weight gain	0.00% 0/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Immune system disorders Skin rash or allergy	80.0% 4/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Diminished mental acuity/sharpness	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Difficulties finding words	60.0% 3/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	0.00% 0/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Apathy/emotional indifference	0.00% 0/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Vascular disorders Dizziness when you stand up	0.00% 0/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Blood and lymphatic system disorders Bruising	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	14.3% 1/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Endocrine disorders Hot flashes	20.0% 1/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	0.00% 0/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Clenching of teeth at night	0.00% 0/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	28.6% 2/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
Nervous system disorders Unable to sit still	0.00% 0/5 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).	42.9% 3/7 • Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).