Trial Outcomes & Findings for A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD (NCT NCT01532999)
NCT ID: NCT01532999
Last Updated: 2015-04-08
Results Overview
Clinician Administered PTSD Scale (CAPS) is a 17-item standard rating scale that measures PTSD severity with scores ranging from 0-136 (higher score = more severe). Scores of frequency and intensity are summed for the 17-items to yield the total CAPS score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
254 participants
Primary outcome timeframe
Baseline to week 9
Results posted on
2015-04-08
Participant Flow
254 participants signed informed consent; 214 participants were randomized; and 191 randomized participants attended at least one MBSR or PCGT session and were included in the modified intent-to-treat analysis for which results are displayed.
Participant milestones
| Measure |
Mindfulness Based Stress Reduction
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
95
|
|
Overall Study
COMPLETED
|
65
|
77
|
|
Overall Study
NOT COMPLETED
|
31
|
18
|
Reasons for withdrawal
| Measure |
Mindfulness Based Stress Reduction
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
8
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Relocated
|
2
|
0
|
|
Overall Study
should not have been randomized
|
1
|
0
|
|
Overall Study
substantial noncompliance
|
2
|
0
|
|
Overall Study
no show for week 9 assessments
|
6
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
incarcerated
|
0
|
1
|
|
Overall Study
New job
|
0
|
2
|
Baseline Characteristics
A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD
Baseline characteristics by cohort
| Measure |
Mindfulness Based Stress Reduction
n=96 Participants
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 Participants
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 11 • n=5 Participants
|
51 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
51 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
63 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
CAPS Total
|
84.3 units on a scale
STANDARD_DEVIATION 19.5 • n=5 Participants
|
80.7 units on a scale
STANDARD_DEVIATION 16.7 • n=7 Participants
|
83 units on a scale
STANDARD_DEVIATION 18.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 9Population: All participants who were randomized and attended at least one intervention session.
Clinician Administered PTSD Scale (CAPS) is a 17-item standard rating scale that measures PTSD severity with scores ranging from 0-136 (higher score = more severe). Scores of frequency and intensity are summed for the 17-items to yield the total CAPS score.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=96 Participants
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 Participants
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
Change From Baseline in Clinician Administered PTSD Scale
|
-22.4 units on a scale
Standard Deviation 27
|
-15.9 units on a scale
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: Baseline to week 9Population: All participants who were randomized and attended at least one intervention session.
PTSD Checklist (PCL) is a 17-item self-report scale intended to measure PTSD symptom severity. The PCL has demonstrated excellent internal consistency (alpha = .94-.97), and test-retest reliability over 2 to 3 days was .96 for Vietnam veterans. Respondents rate each item from 1 ("not at all") to 5 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month. Thus, total possible scores (items summed) range from 17 to 85 (higher score is more severe). A cut-off score of 50 indicates a probable diagnosis of PTSD.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=96 Participants
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 Participants
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
Change From Baseline in PTSD Checklist (PCL)
|
-8.6 units on a scale
Standard Deviation 15.8
|
-6.7 units on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Baseline to week 9Population: All participants who were randomized and attended at least one intervention session.
Five Facet Mindfulness Questionnaire (FFMQ) is used to evaluate the effects of MBSR vs. PCGT on mindfulness (S1). The FFMQ is a 39-item self-report instrument that assesses the general tendency to be mindful in daily life through 5 facets: observing, describing, acting with awareness, non-judging of inner experience, non-reactivity to inner experience. Increases in FFMQ mediate improvements in well being in observational studies of MBSR. Each item is rated 1 to 5 ("never or very rarely true" to "very often or always true"). Some of the items are reverse scored (R). Scoring Information: Observe items:1, 6, 11, 15, 20, 26, 31, 36; Describe items: 2, 7, 12R, 16R, 22R, 27, 32, 37; Act with Awareness items: 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R; Nonjudge items: 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R; Nonreact items: 4, 9, 19, 21, 24, 29, 33. Total all subscales for score (higher score = greater degree of mindfulness). Score range 39-195 with higher=more mindfulness.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=96 Participants
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 Participants
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
Change From Baseline in Five Facet Mindfulness Questionnaire (FFMQ)
|
5.2 units on a scale
Standard Deviation 16.6
|
2.1 units on a scale
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Baseline to week 9Population: All participants who were randomized and attended at least one intervention session.
Patient Health Questionnaire (PHQ-9) is a brief 9-item measure of depressive symptoms that has established reliability and validity in community and clinical populations. All items are summed for total score ranging from 0 to 27 (higher score = more severe depression).
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=96 Participants
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 Participants
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
Change From Baseline in Patient Health Questionnaire (PHQ-9)
|
-3.2 units on a scale
Standard Deviation 6.6
|
-1.6 units on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline to week 9Population: All participants who were randomized and attended at least one intervention session.
Clinician Administered PTSD Scale (CAPS) B subscale measures the re-experiencing cluster (i.e. B criterion) of PTSD symptoms and includes the first 5 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=96 Participants
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 Participants
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
Change From Baseline in CAPS B Subscale
|
-7.7 units on a scale
Standard Deviation 10.4
|
-6.2 units on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Baseline to week 9Population: All participants who were randomized and attended at least one intervention session.
Clinician Administered PTSD Scale (CAPS) C subscale measures the avoidance and emotional numbing cluster (i.e. C criterion) of PTSD symptoms and includes the items 6 - 12 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 56 (higher score = more severe PTSD).
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=96 Participants
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 Participants
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
Change From Baseline in CAPS C Subscale
|
-8.8 units on a scale
Standard Deviation 12.6
|
-6.8 units on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Baseline to week 9Population: All participants who were randomized and attended at least one intervention session.
Clinician Administered PTSD Scale (CAPS) D subscale measures the hyperarousal cluster (i.e. D criterion) of PTSD symptoms and includes the items 13 - 17 of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=96 Participants
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 Participants
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
Change From Baseline in CAPS D Subscale
|
-5.9 units on a scale
Standard Deviation 9.3
|
-3 units on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline to week 9Population: All participants who were randomized and attended at least one intervention session.
Greater than or equal to 30% improvement on PTSD CAPS scale
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=96 Participants
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 Participants
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
PTSD Response
|
45.2 percentage of participants
|
37.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 9Population: All participants who were randomized and attended at least one intervention session.
Total CAPS score of less than or equal to 45 at week 9 (single observation point)
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=96 Participants
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 Participants
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
PTSD Remission
|
30.7 percentage of participants
|
27.3 percentage of participants
|
Adverse Events
Mindfulness Based Stress Reduction
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Present Centered Group Therapy
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mindfulness Based Stress Reduction
n=96 participants at risk
Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
|
Present Centered Group Therapy
n=95 participants at risk
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
|
|---|---|---|
|
Infections and infestations
wisdom tooth infection
|
1.0%
1/96 • Number of events 1 • Adverse events were collected during the 17 week follow-up period for each participant.
|
0.00%
0/95 • Adverse events were collected during the 17 week follow-up period for each participant.
|
|
Psychiatric disorders
suicidal and homicidal feelings
|
3.1%
3/96 • Number of events 3 • Adverse events were collected during the 17 week follow-up period for each participant.
|
2.1%
2/95 • Number of events 2 • Adverse events were collected during the 17 week follow-up period for each participant.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/96 • Adverse events were collected during the 17 week follow-up period for each participant.
|
1.1%
1/95 • Number of events 1 • Adverse events were collected during the 17 week follow-up period for each participant.
|
|
Reproductive system and breast disorders
swollen scrotum
|
0.00%
0/96 • Adverse events were collected during the 17 week follow-up period for each participant.
|
1.1%
1/95 • Number of events 1 • Adverse events were collected during the 17 week follow-up period for each participant.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place