Trial Outcomes & Findings for Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder (NCT NCT05132699)
NCT ID: NCT05132699
Last Updated: 2024-10-10
Results Overview
The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders v5 (DSM-5) criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Subscale scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of PTSD. Scores range from 0 to 80. Change in score will be reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline and at about 45 days (1 month follow-up visit)
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
Cannabidiol (CBD)
Epidiolex oral solution 500mg (5ml) per day
Cannabidiol (CBD) oral solution: An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
Placebo
Placebo oral solution 5ml per day
Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Cannabidiol (CBD)
Epidiolex oral solution 500mg (5ml) per day
Cannabidiol (CBD) oral solution: An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
Placebo
Placebo oral solution 5ml per day
Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
21 were randomized into CBD (n=11) or placebo (n=10). 1 individual in the placebo condition was not included in analyses (A PI drop due to participant non-compliance and loss of eligibility. Data gathered from this participant was not evaluable).
Baseline characteristics by cohort
| Measure |
Cannabidiol (CBD)
n=11 Participants
Epidiolex oral solution 500mg (5ml) per day
Cannabidiol (CBD) oral solution: An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
Placebo
n=10 Participants
Placebo oral solution 5ml per day
Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 12.2 • n=5 Participants • 21 were randomized into CBD (n=11) or placebo (n=10). 1 individual in the placebo condition was not included in analyses (A PI drop due to participant non-compliance and loss of eligibility. Data gathered from this participant was not evaluable).
|
38.9 years
STANDARD_DEVIATION 8.5 • n=7 Participants • 21 were randomized into CBD (n=11) or placebo (n=10). 1 individual in the placebo condition was not included in analyses (A PI drop due to participant non-compliance and loss of eligibility. Data gathered from this participant was not evaluable).
|
42.5 years
STANDARD_DEVIATION 11.0 • n=5 Participants • 21 were randomized into CBD (n=11) or placebo (n=10). 1 individual in the placebo condition was not included in analyses (A PI drop due to participant non-compliance and loss of eligibility. Data gathered from this participant was not evaluable).
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black, Non-Hispanic
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White, Hispanic
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White, Non-Hispanic
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and at about 45 days (1 month follow-up visit)Population: Intent to treat analysis were completed in the total sample (n=21; CBD = 11, Placebo = 10).
The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders v5 (DSM-5) criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Subscale scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of PTSD. Scores range from 0 to 80. Change in score will be reported.
Outcome measures
| Measure |
Cannabidiol (CBD)
n=11 Participants
Epidiolex oral solution 500mg (5ml) per day
Cannabidiol (CBD) oral solution: An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
Placebo
n=10 Participants
Placebo oral solution 5ml per day
Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
|---|---|---|
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Clinician Administered PTSD Scale (CAPS-5)
Baseline
|
42.8 score on a scale
Standard Error 2.3
|
42.9 score on a scale
Standard Error 2.2
|
|
Clinician Administered PTSD Scale (CAPS-5)
1-Month Follow-Up
|
15.2 score on a scale
Standard Error 2.6
|
10.1 score on a scale
Standard Error 2.6
|
PRIMARY outcome
Timeframe: Baseline and at about 45 days (1 month follow-up visit)Population: Intent to treat analysis were completed in the total sample (n=21; CBD = 11, Placebo = 10).
The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). Scores range from 0 to 80 with a higher score indicating that subjects have been bothered more by PTSD symptoms. Change in score will be reported.
Outcome measures
| Measure |
Cannabidiol (CBD)
n=11 Participants
Epidiolex oral solution 500mg (5ml) per day
Cannabidiol (CBD) oral solution: An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
Placebo
n=10 Participants
Placebo oral solution 5ml per day
Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist (PCL-5)
Baseline
|
50.8 score on a scale
Standard Error 0.9
|
52.1 score on a scale
Standard Error 0.9
|
|
Posttraumatic Stress Disorder Checklist (PCL-5)
1-Month Follow-Up
|
19.97 score on a scale
Standard Error 7.6
|
27.3 score on a scale
Standard Error 8.1
|
SECONDARY outcome
Timeframe: Baseline and at about 45 Days (1 month follow-up visit)Population: Intent to treat analysis were completed in the total sample (n=21; CBD = 11, Placebo = 10).
It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders; these 9 items correspond to the diagnostic criteria for Diagnostic Statistical Manual of Mental Disorders - Major Depressive Disorder (DSM MDD). Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores on all items are summed to obtain a total severity score between 0 and 27. Scores reflect no significant depressive symptoms (0-4), mild depressive symptoms (5-9), moderate depressive symptoms (10-14), moderately severe depressive symptoms (15-19), and severe depressive symptoms (\>19). Change in score is reported.
Outcome measures
| Measure |
Cannabidiol (CBD)
n=11 Participants
Epidiolex oral solution 500mg (5ml) per day
Cannabidiol (CBD) oral solution: An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
Placebo
n=10 Participants
Placebo oral solution 5ml per day
Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Baseline
|
14.6 score on a scale
Standard Error 0.5
|
15.5 score on a scale
Standard Error 0.5
|
|
Patient Health Questionnaire-9 (PHQ-9)
1-Month Follow-Up
|
5.4 score on a scale
Standard Error 2.4
|
7.3 score on a scale
Standard Error 2.4
|
Adverse Events
Cannabidiol (CBD)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cannabidiol (CBD)
n=11 participants at risk
Epidiolex oral solution 500mg (5ml) per day
Cannabidiol (CBD) oral solution: An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
Placebo
n=10 participants at risk
Placebo oral solution 5ml per day
Placebo: An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day
Massed Prolonged Exposure (mPE): mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Issues
|
36.4%
4/11 • Number of events 4 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
20.0%
2/10 • Number of events 2 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
|
Psychiatric disorders
Emotional Problems
|
27.3%
3/11 • Number of events 3 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
10.0%
1/10 • Number of events 1 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
|
Psychiatric disorders
Fatigue
|
18.2%
2/11 • Number of events 2 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
30.0%
3/10 • Number of events 3 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
|
Psychiatric disorders
Sleep Disturbance
|
36.4%
4/11 • Number of events 4 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
0.00%
0/10 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
|
General disorders
Sensation from study drug
|
0.00%
0/11 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
20.0%
2/10 • Number of events 2 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
|
General disorders
Appetite Increase
|
0.00%
0/11 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
10.0%
1/10 • Number of events 1 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
|
Nervous system disorders
Drowsiness
|
9.1%
1/11 • Number of events 1 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
0.00%
0/10 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.00%
0/11 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
10.0%
1/10 • Number of events 1 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
|
Psychiatric disorders
Physiological Arousal
|
9.1%
1/11 • Number of events 1 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
0.00%
0/10 • Enrolled participants were monitored for AEs at Interim Assessment 1 (PE Session 1), Interim Assessment 2 (PE Session 5), Interim Assessment 3 (PE Session 10), and at the 1-month follow-up.
AEs were assessed/monitored using standardized procedures. At each assessment period, participants were asked "Have you experienced any changes for the worse since your last visit?" Reported events were documented by the research team member. Participants were asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related. AEs were reviewed during biweekly study meetings to ensure reliable coding and participant safety.
|
Additional Information
Casey Straud
University of Texas Health Science Center at San Antonio
Phone: 210-562-6742
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place