Trial Outcomes & Findings for Methylphenidate for Ptsd and Stroke Veterans (NCT NCT04885257)
NCT ID: NCT04885257
Last Updated: 2025-06-22
Results Overview
The modified Ranking scale (mRS) is a single-item, global, Likert-type scale ranging from 0-6 (higher scores mean a worse outcome) to categorize level of functional independence with comparison to pre-stroke function, accounting for activities of daily living. Participants were scored at baseline, Week 4, Week 8, Week 12, and 30 days after tapering after methylphenidate/placebo. The mean change from baseline at Week 12 for each group is reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From baseline to Week 12
Results posted on
2025-06-22
Participant Flow
Participant milestones
| Measure |
Placebo
Patient with both PTSD and recent history of stroke. Placebo control arm. The frequency will be up to twice a day, with oral dosing.
Placebo: Placebo arm
|
Methylphenidate
Patient with both PTSD and recent history of stroke. Methylphenidate active arm. The oral dosing maximum will be up to 20mg twice daily.
Methylphenidate: Methylphenidate oral pill. Dosing instructions given to
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Patient with both PTSD and recent history of stroke. Placebo control arm. The frequency will be up to twice a day, with oral dosing.
Placebo: Placebo arm
|
Methylphenidate
Patient with both PTSD and recent history of stroke. Methylphenidate active arm. The oral dosing maximum will be up to 20mg twice daily.
Methylphenidate: Methylphenidate oral pill. Dosing instructions given to
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Methylphenidate for Ptsd and Stroke Veterans
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Patient with both PTSD and recent history of stroke. Placebo control arm. The frequency will be up to twice a day, with oral dosing.
Placebo: Placebo arm
|
Methylphenidate
n=10 Participants
Patient with both PTSD and recent history of stroke. Methylphenidate active arm. The oral dosing maximum will be up to 20mg twice daily.
Methylphenidate: Methylphenidate oral pill. Dosing instructions given to
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.30 years
STANDARD_DEVIATION 11.57 • n=93 Participants
|
65.00 years
STANDARD_DEVIATION 6.39 • n=4 Participants
|
63.65 years
STANDARD_DEVIATION 9.20 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 12Population: Only participants completing both the baseline and Week 12 mRS assessment were included in this analysis. One participant in the placebo group withdrew before Week 12 so is not included here.
The modified Ranking scale (mRS) is a single-item, global, Likert-type scale ranging from 0-6 (higher scores mean a worse outcome) to categorize level of functional independence with comparison to pre-stroke function, accounting for activities of daily living. Participants were scored at baseline, Week 4, Week 8, Week 12, and 30 days after tapering after methylphenidate/placebo. The mean change from baseline at Week 12 for each group is reported.
Outcome measures
| Measure |
Placebo
n=9 Participants
Patient with both PTSD and recent history of stroke. Placebo control arm. The frequency will be up to twice a day, with oral dosing.
Placebo: Placebo arm
|
Methylphenidate
n=10 Participants
Patient with both PTSD and recent history of stroke. Methylphenidate active arm. The oral dosing maximum will be up to 20mg twice daily.
Methylphenidate: Methylphenidate oral pill. Dosing instructions given to
|
|---|---|---|
|
Change in Modified Rankin Scale at 12 Weeks
|
-0.44 units on a scale
Standard Deviation 0.53
|
-0.50 units on a scale
Standard Deviation 1.08
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Methylphenidate
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Patient with both PTSD and recent history of stroke. Placebo control arm. The frequency will be up to twice a day, with oral dosing.
Placebo: Placebo arm
|
Methylphenidate
n=10 participants at risk
Patient with both PTSD and recent history of stroke. Methylphenidate active arm. The oral dosing maximum will be up to 20mg twice daily.
Methylphenidate: Methylphenidate oral pill. Dosing instructions given to
|
|---|---|---|
|
Infections and infestations
Hospitalization due to infectious illness
|
0.00%
0/10 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
10.0%
1/10 • Number of events 1 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
|
Cardiac disorders
Cardiac arrhythmia
|
10.0%
1/10 • Number of events 1 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
0.00%
0/10 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
|
General disorders
Hospitalization
|
0.00%
0/10 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
10.0%
1/10 • Number of events 1 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Patient with both PTSD and recent history of stroke. Placebo control arm. The frequency will be up to twice a day, with oral dosing.
Placebo: Placebo arm
|
Methylphenidate
n=10 participants at risk
Patient with both PTSD and recent history of stroke. Methylphenidate active arm. The oral dosing maximum will be up to 20mg twice daily.
Methylphenidate: Methylphenidate oral pill. Dosing instructions given to
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
0.00%
0/10 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
10.0%
1/10 • Number of events 1 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
0.00%
0/10 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
0.00%
0/10 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
|
Nervous system disorders
Speech abnormality
|
10.0%
1/10 • Number of events 1 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
0.00%
0/10 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Number of events 1 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
10.0%
1/10 • Number of events 1 • 12 week study period and the 30 day tapering off methylphenidate/placebo.
|
Additional Information
Research Compliance Officer
Birmingham VA Medical Center
Phone: 205-933-8101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place