Trial Outcomes & Findings for Efficacy and Tolerability of Riluzole in Treatment Resistant Depression (NCT NCT01204918)
NCT ID: NCT01204918
Last Updated: 2020-03-06
Results Overview
This 10 item instrument is completed by the clinician by using a structured interview and defined anchor points, and aims to quantify the degree of depression over the past 7 days. The MADRS is a widely studied instrument for depression, and its reliability and validity are high. This instrument is administered at every study visit during the double-blind RCT, and at the screening, and baseline. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
4 weeks of therapy (baseline to week 4)
Results posted on
2020-03-06
Participant Flow
Participant milestones
| Measure |
Riluzole Addition to SSRI Antidepressant
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks
Riluzole: Riluzole 100mg PO
|
Riluzole/Placebo Addition to SSRI Antidepressant
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks
Riluzole: Riluzole 100mg PO
placebo: placebo
|
Placebo Addition to Standard SSRI Antidepressant
Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks
placebo: placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
39
|
40
|
|
Overall Study
Stage 1 Begin
|
25
|
39
|
40
|
|
Overall Study
Stage 1 End
|
22
|
35
|
36
|
|
Overall Study
Stage 2 Begin
|
22
|
35
|
36
|
|
Overall Study
Stage 2 End
|
21
|
29
|
35
|
|
Overall Study
COMPLETED
|
21
|
29
|
35
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
5
|
Reasons for withdrawal
| Measure |
Riluzole Addition to SSRI Antidepressant
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks
Riluzole: Riluzole 100mg PO
|
Riluzole/Placebo Addition to SSRI Antidepressant
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks
Riluzole: Riluzole 100mg PO
placebo: placebo
|
Placebo Addition to Standard SSRI Antidepressant
Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks
placebo: placebo
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
5
|
Baseline Characteristics
Efficacy and Tolerability of Riluzole in Treatment Resistant Depression
Baseline characteristics by cohort
| Measure |
Riluzole Addition to SSRI Antidepressant
n=25 Participants
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks
Riluzole: Riluzole 100mg PO
|
Riluzole/Placebo Addition to SSRI Antidepressant
n=39 Participants
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks
Riluzole: Riluzole 100mg PO
placebo: placebo
|
Placebo Addition to Standard SSRI Antidepressant
n=40 Participants
Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks
placebo: placebo
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Antidepressant (Y/N)
Yes
|
16 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Antidepressant (Y/N)
No
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks of therapy (baseline to week 4)This 10 item instrument is completed by the clinician by using a structured interview and defined anchor points, and aims to quantify the degree of depression over the past 7 days. The MADRS is a widely studied instrument for depression, and its reliability and validity are high. This instrument is administered at every study visit during the double-blind RCT, and at the screening, and baseline. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
Outcome measures
| Measure |
Riluzole Addition to SSRI Antidepressant
n=25 Participants
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks
Riluzole: Riluzole 100mg PO
|
Riluzole/Placebo Addition to SSRI Antidepressant
n=39 Participants
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks
Riluzole: Riluzole 100mg PO
placebo: placebo
|
Placebo Addition to Standard SSRI Antidepressant
n=40 Participants
Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks
placebo: placebo
|
|---|---|---|---|
|
Change in Montgomery and Asberg Depression Rating Scale (MADRS)
|
3.20 units on a scale
Standard Deviation 3.86
|
5.77 units on a scale
Standard Deviation 0.52
|
4.83 units on a scale
Standard Deviation 7.85
|
PRIMARY outcome
Timeframe: 4 weeks of therapy (week 4 to week 8)This 10 item instrument is completed by the clinician by using a structured interview and defined anchor points, and aims to quantify the degree of depression over the past 7 days. The MADRS is a widely studied instrument for depression, and its reliability and validity are high. This instrument is administered at every study visit during the double-blind RCT, and at the screening, and baseline. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
Outcome measures
| Measure |
Riluzole Addition to SSRI Antidepressant
n=25 Participants
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks
Riluzole: Riluzole 100mg PO
|
Riluzole/Placebo Addition to SSRI Antidepressant
n=39 Participants
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks
Riluzole: Riluzole 100mg PO
placebo: placebo
|
Placebo Addition to Standard SSRI Antidepressant
n=40 Participants
Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks
placebo: placebo
|
|---|---|---|---|
|
Change in Montgomery and Asberg Depression Rating Scale (MADRS)
|
4.13 units on a scale
Standard Deviation 6.82
|
0.84 units on a scale
Standard Deviation 5.79
|
3.87 units on a scale
Standard Deviation 6.49
|
SECONDARY outcome
Timeframe: 8 weeks therapyResponders having at least a 50% improvement in MADRS compared to the baseline in the sequential parallel design
Outcome measures
| Measure |
Riluzole Addition to SSRI Antidepressant
n=25 Participants
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks
Riluzole: Riluzole 100mg PO
|
Riluzole/Placebo Addition to SSRI Antidepressant
n=39 Participants
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks
Riluzole: Riluzole 100mg PO
placebo: placebo
|
Placebo Addition to Standard SSRI Antidepressant
n=40 Participants
Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks
placebo: placebo
|
|---|---|---|---|
|
Responders Having at Least a 50% Improvement in MADRS Compared to the Baseline
|
6 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All subjects are included in the analysis- with the exception of sex specific conditions.
A commonly used instrument originally developed by NIMH and adapted into a self-report instrument. The version of the scale that we plan to use examines in a systematic fashion all possible treatment-emergent side effects and probes specific adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior. Presented below are counts of people that had experienced the event by 8 weeks.
Outcome measures
| Measure |
Riluzole Addition to SSRI Antidepressant
n=25 Participants
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks
Riluzole: Riluzole 100mg PO
|
Riluzole/Placebo Addition to SSRI Antidepressant
n=39 Participants
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks
Riluzole: Riluzole 100mg PO
placebo: placebo
|
Placebo Addition to Standard SSRI Antidepressant
n=40 Participants
Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks
placebo: placebo
|
|---|---|---|---|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Poor Concentration
|
16 participants
|
28 participants
|
25 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Abnormal Sensation
|
3 participants
|
5 participants
|
3 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Numbness/Tingling
|
2 participants
|
8 participants
|
4 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Headache
|
8 participants
|
14 participants
|
13 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Blurred Vision
|
5 participants
|
8 participants
|
5 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Muscle Twitch
|
7 participants
|
10 participants
|
6 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Poor Coordination
|
6 participants
|
11 participants
|
5 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Difficulty Urinating
|
4 participants
|
6 participants
|
1 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Delayed/Absent Orgasm
|
9 participants
|
19 participants
|
16 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Sweating Excessively
|
9 participants
|
10 participants
|
14 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Weight Gain
|
7 participants
|
8 participants
|
15 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Skin Rash
|
3 participants
|
4 participants
|
3 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Diminished Mental Acuity
|
16 participants
|
22 participants
|
22 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Difficulty Finding Words
|
15 participants
|
21 participants
|
18 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Trouble Sleeping
|
17 participants
|
24 participants
|
21 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Nightmares
|
9 participants
|
15 participants
|
11 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Drowsy
|
14 participants
|
25 participants
|
22 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Nervousness
|
13 participants
|
19 participants
|
14 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Fatigue
|
14 participants
|
26 participants
|
28 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Irratibility
|
15 participants
|
22 participants
|
23 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Poor Memory
|
16 participants
|
23 participants
|
24 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Strange Feeling/Unreal
|
4 participants
|
7 participants
|
5 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Hearing/Seeing Things
|
1 participants
|
2 participants
|
1 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Dizziness
|
7 participants
|
10 participants
|
4 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Ringing Ears
|
4 participants
|
9 participants
|
8 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Stuffy Nose
|
5 participants
|
14 participants
|
10 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Dry mouth
|
3 participants
|
10 participants
|
10 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Drooling/Salivation
|
2 participants
|
4 participants
|
0 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Muscle Cramp
|
5 participants
|
16 participants
|
12 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Trouble Sitting
|
9 participants
|
16 participants
|
14 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Tremors/Shakiness
|
8 participants
|
9 participants
|
6 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Slurred Speech
|
1 participants
|
5 participants
|
3 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Rapid Heartbeat
|
8 participants
|
13 participants
|
9 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Hyperventilation
|
6 participants
|
7 participants
|
3 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Chest Pain
|
4 participants
|
6 participants
|
2 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Nausea/Vomiting
|
3 participants
|
5 participants
|
3 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Stomach Discomfort
|
5 participants
|
12 participants
|
9 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Constipation
|
3 participants
|
5 participants
|
10 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Diarrhea
|
2 participants
|
7 participants
|
11 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Frequent Urination
|
7 participants
|
10 participants
|
6 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Menstrual Irregularities
|
0 participants
|
2 participants
|
1 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Loss of Sexual Interest
|
13 participants
|
26 participants
|
22 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Sexual Performance Problems
|
12 participants
|
20 participants
|
16 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Fluid Retention
|
4 participants
|
6 participants
|
8 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Decreased Appetite
|
5 participants
|
7 participants
|
8 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Increased Appetite
|
8 participants
|
8 participants
|
15 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Weight Loss
|
5 participants
|
7 participants
|
7 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Apathy Emotional Indifference
|
11 participants
|
18 participants
|
21 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Dizzy When Standing Up
|
8 participants
|
10 participants
|
2 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Bruising
|
4 participants
|
2 participants
|
2 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Hair Thinning
|
2 participants
|
6 participants
|
8 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Hot Flashes
|
2 participants
|
7 participants
|
12 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Clenching Teeth
|
4 participants
|
13 participants
|
7 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Strange Taste in Mouth
|
3 participants
|
8 participants
|
5 participants
|
|
Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)
Unable to Sit Still
|
9 participants
|
17 participants
|
14 participants
|
Adverse Events
Riluzole Addition to SSRI Antidepressant
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Riluzole/Placebo Addition to SSRI Antidepressant
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo Addition to Standard SSRI Antidepressant
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Riluzole Addition to SSRI Antidepressant
n=25 participants at risk
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks
Riluzole: Riluzole 100mg PO
|
Riluzole/Placebo Addition to SSRI Antidepressant
n=39 participants at risk
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks
Riluzole: Riluzole 100mg PO
placebo: placebo
|
Placebo Addition to Standard SSRI Antidepressant
n=40 participants at risk
Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks
placebo: placebo
|
|---|---|---|---|
|
Nervous system disorders
Global Amnesia
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.5%
1/40 • Number of events 1 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
4.0%
1/25 • Number of events 1 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.5%
1/40 • Number of events 1 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
Other adverse events
| Measure |
Riluzole Addition to SSRI Antidepressant
n=25 participants at risk
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks
Riluzole: Riluzole 100mg PO
|
Riluzole/Placebo Addition to SSRI Antidepressant
n=39 participants at risk
Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks
Riluzole: Riluzole 100mg PO
placebo: placebo
|
Placebo Addition to Standard SSRI Antidepressant
n=40 participants at risk
Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks
placebo: placebo
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
7.7%
3/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Sexual Dysfunction
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.1%
2/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.5%
1/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Sleep Disturbance
|
8.0%
2/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.1%
2/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
10.0%
4/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Drowsiness
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.1%
2/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.5%
1/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Abdominal Pain
|
8.0%
2/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.6%
1/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Back Pain
|
12.0%
3/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
7.7%
3/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
10.0%
4/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Eye disorders
Blurred Vision
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
7.5%
3/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Body Aches
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Clenching Teeth
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.1%
2/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.5%
1/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Infections and infestations
Cold/Flu Symptoms
|
12.0%
3/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
33.3%
13/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
12.5%
5/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
7.7%
3/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.5%
1/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
3/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
17.9%
7/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
15.0%
6/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Dizziness
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
10.3%
4/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
7.5%
3/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Fall
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Fatigue
|
20.0%
5/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
15.4%
6/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
20.0%
8/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Renal and urinary disorders
Frequent Urination
|
8.0%
2/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.1%
2/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Gastrointestinal disorders
GI Issues
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
7.7%
3/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
12.5%
5/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Headache
|
28.0%
7/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
28.2%
11/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
20.0%
8/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Insomnia
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
7.7%
3/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Leg Pain/Stiffness
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
10.3%
4/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
7.5%
3/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.6%
1/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Infections and infestations
Nasal Congestion/Pain
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
20.5%
8/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
27.5%
11/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Nightmares
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.1%
2/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.5%
1/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Nervous system disorders
Numbness
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.1%
2/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.5%
1/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.6%
1/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.1%
2/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.5%
1/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Nervous system disorders
Sweating
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Nervous system disorders
Tingling Sensation
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.1%
2/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
2.5%
1/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Toothache
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
General disorders
Vivid Dreams
|
4.0%
1/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
0.00%
0/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.0%
2/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
5.1%
2/39 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
7.5%
3/40 • 8 weeks
These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
|
Additional Information
Gerard Sanacora, PhD, MD: Professor of Psychiatry; Director, Yale Depression Research Program
Yale University
Phone: (203) 974-7535
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place