Trial Outcomes & Findings for Ketamine-enhanced Prolonged Exposure Therapy in PTSD (NCT NCT04560660)
NCT ID: NCT04560660
Last Updated: 2026-08-11
Results Overview
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Baseline
Results posted on
2026-08-11
Participant Flow
73 participants were randomized and received at least one treatment infusion
Participant milestones
| Measure |
Ketamine and Prolonged Exposure (PE)
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Midazolam and Prolonged Exposure (PE)
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
| Measure |
Ketamine and Prolonged Exposure (PE)
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Midazolam and Prolonged Exposure (PE)
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Lack of Efficacy
|
6
|
9
|
Baseline Characteristics
One subject in the midazolam and prolonged exposure group did not complete MADRS
Baseline characteristics by cohort
| Measure |
Ketamine and Prolonged Exposure (PE)
n=37 Participants
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Midazolam and Prolonged Exposure (PE)
n=36 Participants
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 11.4 • n=37 Participants
|
44.2 years
STANDARD_DEVIATION 12.5 • n=36 Participants
|
45.0 years
STANDARD_DEVIATION 11.9 • n=73 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=37 Participants
|
10 Participants
n=36 Participants
|
21 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=37 Participants
|
26 Participants
n=36 Participants
|
52 Participants
n=73 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=73 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=37 Participants
|
32 Participants
n=36 Participants
|
65 Participants
n=73 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=37 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=73 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=37 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=73 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=37 Participants
|
35 Participants
n=36 Participants
|
70 Participants
n=73 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=73 Participants
|
|
PTSD Checklist for DSM-5 (PCL-5)
|
56.7 units on a scale
STANDARD_DEVIATION 12.0 • n=37 Participants
|
54.3 units on a scale
STANDARD_DEVIATION 10.5 • n=36 Participants
|
55.5 units on a scale
STANDARD_DEVIATION 11.3 • n=73 Participants
|
|
Beck Anxiety Inventory (BAI)
|
31.7 units on a scale
STANDARD_DEVIATION 12.4 • n=37 Participants
|
31.6 units on a scale
STANDARD_DEVIATION 12.7 • n=36 Participants
|
31.7 units on a scale
STANDARD_DEVIATION 12.4 • n=73 Participants
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
|
32.9 units on a scale
STANDARD_DEVIATION 7.3 • n=37 Participants • One subject in the midazolam and prolonged exposure group did not complete MADRS
|
33.5 units on a scale
STANDARD_DEVIATION 6.6 • n=35 Participants • One subject in the midazolam and prolonged exposure group did not complete MADRS
|
33.2 units on a scale
STANDARD_DEVIATION 6.9 • n=72 Participants • One subject in the midazolam and prolonged exposure group did not complete MADRS
|
PRIMARY outcome
Timeframe: BaselinePopulation: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Outcome measures
| Measure |
Midazolam and Prolonged Exposure (PE)
n=36 Participants
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Ketamine and Prolonged Exposure (PE)
n=37 Participants
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
|
41.9 units on a scale
Standard Deviation 11.0
|
42.1 units on a scale
Standard Deviation 9.3
|
PRIMARY outcome
Timeframe: Week 4Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Outcome measures
| Measure |
Midazolam and Prolonged Exposure (PE)
n=19 Participants
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Ketamine and Prolonged Exposure (PE)
n=25 Participants
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
|
36.7 units on a scale
Standard Deviation 13.0
|
34.0 units on a scale
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: Week 10Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Outcome measures
| Measure |
Midazolam and Prolonged Exposure (PE)
n=10 Participants
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Ketamine and Prolonged Exposure (PE)
n=13 Participants
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
|
26.8 units on a scale
Standard Deviation 16.8
|
25.3 units on a scale
Standard Deviation 17.0
|
PRIMARY outcome
Timeframe: Week 14Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Outcome measures
| Measure |
Midazolam and Prolonged Exposure (PE)
n=14 Participants
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Ketamine and Prolonged Exposure (PE)
n=16 Participants
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
|
21.6 units on a scale
Standard Deviation 13.6
|
19.3 units on a scale
Standard Deviation 16.4
|
PRIMARY outcome
Timeframe: Week 22Population: The variability in the number of participants for data points resulted from a variety of reasons for example participants not showing up for appointments, dropping out of the study and/or illness.
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Outcome measures
| Measure |
Midazolam and Prolonged Exposure (PE)
n=13 Participants
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Ketamine and Prolonged Exposure (PE)
n=16 Participants
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
|
19.0 units on a scale
Standard Deviation 13.7
|
18.8 units on a scale
Standard Deviation 13.8
|
Adverse Events
Ketamine and Prolonged Exposure (PE)
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Midazolam and Prolonged Exposure (PE)
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketamine and Prolonged Exposure (PE)
n=37 participants at risk
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Midazolam and Prolonged Exposure (PE)
n=36 participants at risk
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
|---|---|---|
|
Injury, poisoning and procedural complications
alcohol intoxication
|
2.7%
1/37 • Number of events 1 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
0.00%
0/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Psychiatric disorders
suicidal ideations with ER visit
|
0.00%
0/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
2.8%
1/36 • Number of events 1 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
Other adverse events
| Measure |
Ketamine and Prolonged Exposure (PE)
n=37 participants at risk
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
Midazolam and Prolonged Exposure (PE)
n=36 participants at risk
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
|---|---|---|
|
Cardiac disorders
Orthostatism
|
32.4%
12/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
22.2%
8/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Cardiac disorders
Chest pain
|
13.5%
5/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
13.9%
5/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.1%
3/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
19.4%
7/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
29.7%
11/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
22.2%
8/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Renal and urinary disorders
Difficulty urinating
|
8.1%
3/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
2.8%
1/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Renal and urinary disorders
Painful urination
|
0.00%
0/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
8.3%
3/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Renal and urinary disorders
Frequent urination
|
13.5%
5/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
30.6%
11/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Psychiatric disorders
Poor concentration
|
37.8%
14/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
36.1%
13/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Psychiatric disorders
Fatigue
|
54.1%
20/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
36.1%
13/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
General disorders
General malaise
|
32.4%
12/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
19.4%
7/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Psychiatric disorders
Restlessness
|
29.7%
11/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
22.2%
8/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
General disorders
Other
|
29.7%
11/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
38.9%
14/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
32.4%
12/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
25.0%
9/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
37.8%
14/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
22.2%
8/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Gastrointestinal disorders
Constipation
|
43.2%
16/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
11.1%
4/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
24.3%
9/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
36.1%
13/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Cardiac disorders
Skipping a beat
|
13.5%
5/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
5.6%
2/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Skin and subcutaneous tissue disorders
Increased sweating
|
18.9%
7/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
16.7%
6/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Skin and subcutaneous tissue disorders
Itching
|
16.2%
6/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
19.4%
7/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.6%
8/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
13.9%
5/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Nervous system disorders
Headaches
|
54.1%
20/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
38.9%
14/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Nervous system disorders
Tremors
|
18.9%
7/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
13.9%
5/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Nervous system disorders
Poor coordination
|
27.0%
10/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
8.3%
3/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Nervous system disorders
Dizziness
|
40.5%
15/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
33.3%
12/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Eye disorders
Blurred vision
|
32.4%
12/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
8.3%
3/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Reproductive system and breast disorders
Menstrual irregularity
|
0.00%
0/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
8.3%
3/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Psychiatric disorders
Difficulty sleeping
|
59.5%
22/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
61.1%
22/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Psychiatric disorders
Sleeping too much
|
10.8%
4/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
19.4%
7/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Reproductive system and breast disorders
Loss of sexual desire
|
18.9%
7/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
22.2%
8/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Reproductive system and breast disorders
Trouble achieving orgasm
|
10.8%
4/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
8.3%
3/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Reproductive system and breast disorders
Trouble with erections
|
16.2%
6/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
11.1%
4/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Psychiatric disorders
Anxiety
|
51.4%
19/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
44.4%
16/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
|
Psychiatric disorders
Decreased energy
|
43.2%
16/37 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
44.4%
16/36 • from enrollment until end of follow-up (~22 weeks)
Adverse events that occurred at any point during the trial duration. The Patient-Rated Inventory of Side Effects asks subjects to report any adverse event during their research participation without requiring to assess causality related to study procedures or treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place