Trial Outcomes & Findings for Neurosteroids for Treatment of PTSD in Veterans (NCT NCT03799562)
NCT ID: NCT03799562
Last Updated: 2026-08-26
Results Overview
The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make a diagnosis of PTSD and assess PTSD symptoms. It assesses the intensity and frequency of PTSD symptoms. Scores range from 0-80; higher score indicates greater severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Study drug onset to treatment week 8
Results posted on
2026-08-26
Participant Flow
Eligible participants were identified by searching the VA clinical data warehouse for patients with PTSD and residing within a reasonable travel distance from the Durham VA Medical Center, Durham, NC. Potential candidates were enrolled at in-person screening visits between June 2019 and May 2025. Recruitment was on hold from March 2020 - May 2021 due to COVID epidemic restrictions.
Of 236 screened participants, 97 met inclusion criteria and were randomized to treatment. Of the 97 randomized participants, two were later found to be ineligible due to laboratory findings and did not receive actual treatment. Thus in total, 95 participants received study drug. The primary analysis for this phase II study was conducted within treated participants (modified intent-to-treat).
Participant milestones
| Measure |
Pregnenolone
Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
Matching placebo medication dispensed identically with the same number and frequency as the experimental arm
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
43
|
|
Overall Study
Met "Completer" Definition (>=4 Weeks of Treatment)
|
43
|
40
|
|
Overall Study
Primary Endpoint Assessment at Treatment Week 8
|
37
|
37
|
|
Overall Study
COMPLETED
|
37
|
37
|
|
Overall Study
NOT COMPLETED
|
15
|
6
|
Reasons for withdrawal
| Measure |
Pregnenolone
Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
Matching placebo medication dispensed identically with the same number and frequency as the experimental arm
|
|---|---|---|
|
Overall Study
Contraindication to treatment arose
|
7
|
1
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Study pause due to COVID
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Missing current smoking status in one participant
Baseline characteristics by cohort
| Measure |
Pregnenolone
n=52 Participants
Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=43 Participants
Matching placebo medication dispensed identically with the same number and frequency as the experimental arm
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.6 Years
STANDARD_DEVIATION 8.11 • n=52 Participants
|
43.2 Years
STANDARD_DEVIATION 8.72 • n=43 Participants
|
41.7 Years
STANDARD_DEVIATION 8.45 • n=95 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=52 Participants
|
4 Participants
n=43 Participants
|
13 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=52 Participants
|
39 Participants
n=43 Participants
|
82 Participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=52 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=52 Participants
|
0 Participants
n=43 Participants
|
2 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=52 Participants
|
1 Participants
n=43 Participants
|
1 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=52 Participants
|
9 Participants
n=43 Participants
|
30 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=52 Participants
|
32 Participants
n=43 Participants
|
60 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=52 Participants
|
1 Participants
n=43 Participants
|
2 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=52 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=52 Participants
|
3 Participants
n=43 Participants
|
6 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=52 Participants
|
40 Participants
n=43 Participants
|
89 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=52 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=95 Participants
|
|
Weight
|
212 Pounds
STANDARD_DEVIATION 36.1 • n=52 Participants
|
217 Pounds
STANDARD_DEVIATION 43.1 • n=43 Participants
|
214 Pounds
STANDARD_DEVIATION 39.3 • n=95 Participants
|
|
Current smoker
|
9 Participants
n=52 Participants • Missing current smoking status in one participant
|
4 Participants
n=42 Participants • Missing current smoking status in one participant
|
13 Participants
n=94 Participants • Missing current smoking status in one participant
|
PRIMARY outcome
Timeframe: Study drug onset to treatment week 8Population: This summary represents the 74 participants retained to treatment week 8. Of those, 7 participants had incomplete CAPS-5 measures such that the endpoint determination is missing.
The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make a diagnosis of PTSD and assess PTSD symptoms. It assesses the intensity and frequency of PTSD symptoms. Scores range from 0-80; higher score indicates greater severity.
Outcome measures
| Measure |
Pregnenolone
n=34 Participants
Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=33 Participants
Matching placebo medication dispensed identically with the same number and frequency as the experimental arm
|
|---|---|---|
|
Change From Baseline in Clinician Administered PTSD Scale for DSM-5 (Visit 6 - Baseline)
|
-12.30 score on a scale
Interval -15.51 to -9.1
|
-11.06 score on a scale
Interval -14.42 to -7.71
|
SECONDARY outcome
Timeframe: Study drug onset to treatment week 8Population: This summary represents the 74 participants retained to treatment week 8. Of those, 4 participants had incomplete collection of the Brief Pain Inventory measures such that the pain-related endpoint determination is missing.
The Brief Pain Inventory, Short Form (BPI-SF) is a self-reported scale that measures the severity of pain and the interference of pain on function. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain in past 24 hrs, least pain in past 24 hrs, average pain, and pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Outcome measures
| Measure |
Pregnenolone
n=34 Participants
Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=36 Participants
Matching placebo medication dispensed identically with the same number and frequency as the experimental arm
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory, Short Form (Visit 6 - Baseline): Average Pain
|
-0.58 score on a scale
Interval -1.08 to -0.07
|
-0.35 score on a scale
Interval -0.86 to 0.15
|
SECONDARY outcome
Timeframe: Study drug onset to treatment week 8Population: This summary represents the 74 participants retained to treatment week 8. Of those, 5 participants had incomplete collection of the Brief Pain Inventory measures such that the pain-related endpoint determination is missing.
The Brief Pain Inventory, Short Form (BPI-SF) is a self-reported scale that measures the severity of pain and the interference of pain on function. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain in past 24 hrs, least pain in past 24 hrs, average pain, and pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Outcome measures
| Measure |
Pregnenolone
n=34 Participants
Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=35 Participants
Matching placebo medication dispensed identically with the same number and frequency as the experimental arm
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory, Short Form (Visit 6 - Baseline): Average Interference Across 7 Types of Activity
|
-1.22 score on a scale
Interval -1.85 to -0.58
|
-0.68 score on a scale
Interval -1.32 to -0.04
|
SECONDARY outcome
Timeframe: Study drug onset to treatment week 8Population: This summary represents the 74 participants retained to treatment week 8. Of those, 7 participants had incomplete HAM-D measures such that the endpoint determination is missing.
The HAM-D measures the severity of depressive symptoms. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.
Outcome measures
| Measure |
Pregnenolone
n=36 Participants
Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
Placebo
n=31 Participants
Matching placebo medication dispensed identically with the same number and frequency as the experimental arm
|
|---|---|---|
|
Change From Baseline in Hamilton-Depression Inventory (Visit 6 - Baseline)
|
-3.55 score on a scale
Interval -4.84 to -2.26
|
-3.07 score on a scale
Interval -4.47 to -1.67
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Pregnenolone
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=43 participants at risk
Matching placebo medication dispensed identically with the same number and frequency as the experimental arm
|
Pregnenolone
n=52 participants at risk
Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
11.6%
5/43 • Number of events 5 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
15.4%
8/52 • Number of events 9 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Gastrointestinal disorders
Constipation
|
9.3%
4/43 • Number of events 10 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
5.8%
3/52 • Number of events 3 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Increased appetite
|
16.3%
7/43 • Number of events 25 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
21.2%
11/52 • Number of events 21 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Dry mouth
|
18.6%
8/43 • Number of events 27 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
15.4%
8/52 • Number of events 16 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Cardiac disorders
Palpitations
|
2.3%
1/43 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
7.7%
4/52 • Number of events 4 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Cardiac disorders
Peripheral edema
|
2.3%
1/43 • Number of events 2 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Cardiac disorders
Hypotension
|
2.3%
1/43 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
0.00%
0/52 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.0%
3/43 • Number of events 3 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Eye disorders
Blurred vision
|
2.3%
1/43 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
7.7%
4/52 • Number of events 8 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Paresthesia
|
11.6%
5/43 • Number of events 7 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
13.5%
7/52 • Number of events 9 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Insomnia
|
9.3%
4/43 • Number of events 5 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
13.5%
7/52 • Number of events 12 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Irritability
|
9.3%
4/43 • Number of events 4 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
9.6%
5/52 • Number of events 6 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Drowsiness
|
18.6%
8/43 • Number of events 14 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
7.7%
4/52 • Number of events 7 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Decreased appetite
|
9.3%
4/43 • Number of events 6 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
7.7%
4/52 • Number of events 6 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Headache
|
9.3%
4/43 • Number of events 5 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
7.7%
4/52 • Number of events 6 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Sweating
|
4.7%
2/43 • Number of events 3 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
7.7%
4/52 • Number of events 8 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Hypersomnia
|
4.7%
2/43 • Number of events 4 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
7.7%
4/52 • Number of events 4 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Nausea
|
2.3%
1/43 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
7.7%
4/52 • Number of events 4 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Restlessness
|
4.7%
2/43 • Number of events 5 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
5.8%
3/52 • Number of events 5 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Cramps
|
2.3%
1/43 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
5.8%
3/52 • Number of events 4 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Nasal congestion
|
0.00%
0/43 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
5.8%
3/52 • Number of events 4 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Decreased motor activity
|
0.00%
0/43 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
3.8%
2/52 • Number of events 2 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Increased Motor Activity
|
0.00%
0/43 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
3.8%
2/52 • Number of events 2 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Vomiting
|
0.00%
0/43 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
3.8%
2/52 • Number of events 2 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Malaise
|
2.3%
1/43 • Number of events 7 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
General disorders
Tremor
|
0.00%
0/43 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Musculoskeletal and connective tissue disorders
Joint pain/stiffness
|
7.0%
3/43 • Number of events 3 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain/stiffness
|
2.3%
1/43 • Number of events 2 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 2 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Nervous system disorders
Impaired sex performance
|
9.3%
4/43 • Number of events 5 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Nervous system disorders
Decreased interest in sex
|
4.7%
2/43 • Number of events 5 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Nervous system disorders
Urinary retention
|
2.3%
1/43 • Number of events 6 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Nervous system disorders
Confusion
|
0.00%
0/43 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 6 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Nervous system disorders
Increased salivation
|
0.00%
0/43 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
1.9%
1/52 • Number of events 6 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Nervous system disorders
Concentration/Memory
|
4.7%
2/43 • Number of events 5 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
0.00%
0/52 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Nervous system disorders
Nocturnal/Enuresis
|
2.3%
1/43 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
0.00%
0/52 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
9.3%
4/43 • Number of events 9 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
5.8%
3/52 • Number of events 4 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Vascular disorders
DIzziness
|
14.0%
6/43 • Number of events 9 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
9.6%
5/52 • Number of events 5 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Vascular disorders
Cold extremities
|
4.7%
2/43 • Number of events 2 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
0.00%
0/52 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
2.3%
1/43 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
0.00%
0/52 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
|
Nervous system disorders
Myoclonus
|
2.3%
1/43 • Number of events 1 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
0.00%
0/52 • From treatment with study drug until end of follow-up (full participation was through treatment week 8 followed by a follow-up phone call one week after treatment discontinuation). If a participant discontinued treatment prior to treatment week 8, every attempt was made to conduct follow-up one week after discontinuation of treatment.
The Hillside Adverse Events Scale was used to systematically assess a range of pre-defined potential side effects. It was administered via interview at routine in-person visits and phone calls.
|
Additional Information
Jennifer C. Naylor, PhD
VISN 6 MIRECC, U.S. Department of Veterans Affairs, Durham VA Healthcare System
Phone: (919) 286-0411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place