Trial Outcomes & Findings for Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD (NCT NCT02720198)
NCT ID: NCT02720198
Last Updated: 2019-08-14
Results Overview
A ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Total scores will range from 0 to 60. Higher scores indicate greater severity of depressive episodes.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2019-08-14
Participant Flow
Potential participants were identified by self-referral via the printed ad, phone script, the patients' physicians, local health providers, mental health providers, or Duke providers. Others were recommended by PI or Study Coordinator. They assessed and screened at 2 sites, an university hospital and a clinic of the research institute.
One subject was lost to follow up after screening.
Participant milestones
| Measure |
Levomilnacipran
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Levomilnacipran
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD
Baseline characteristics by cohort
| Measure |
Levomilnacipran
n=29 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=31 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
45.34 years
STANDARD_DEVIATION 14.28 • n=99 Participants
|
46.13 years
STANDARD_DEVIATION 11.17 • n=107 Participants
|
45.75 years
STANDARD_DEVIATION 12.67 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
31 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Baseline SSRI
Escitalopram
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Baseline SSRI
Fluoxetine
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Baseline SSRI
Sertraline
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Baseline SSRI
Citalopram
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Baseline SSRI
Paroxetine
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Baseline SSRI
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Baseline Dose of SSRI
mg(Escitalopram)
|
18.89 dose of medication, mg
STANDARD_DEVIATION 3.333 • n=99 Participants
|
16.67 dose of medication, mg
STANDARD_DEVIATION 5.774 • n=107 Participants
|
18.33 dose of medication, mg
STANDARD_DEVIATION 3.892 • n=206 Participants
|
|
Baseline Dose of SSRI
mg(Fluoxetine)
|
53.33 dose of medication, mg
STANDARD_DEVIATION 23.094 • n=99 Participants
|
42.00 dose of medication, mg
STANDARD_DEVIATION 6.325 • n=107 Participants
|
44.62 dose of medication, mg
STANDARD_DEVIATION 11.983 • n=206 Participants
|
|
Baseline Dose of SSRI
mg(Sertraline)
|
170.00 dose of medication, mg
STANDARD_DEVIATION 27.386 • n=99 Participants
|
150.00 dose of medication, mg
STANDARD_DEVIATION 31.623 • n=107 Participants
|
159.09 dose of medication, mg
STANDARD_DEVIATION 30.151 • n=206 Participants
|
|
Baseline Dose of SSRI
mg(Citalopram)
|
21.25 dose of medication, mg
STANDARD_DEVIATION 8.345 • n=99 Participants
|
28.00 dose of medication, mg
STANDARD_DEVIATION 10.954 • n=107 Participants
|
23.85 dose of medication, mg
STANDARD_DEVIATION 9.608 • n=206 Participants
|
|
Baseline Dose of SSRI
mg(Paroxetine)
|
40.00 dose of medication, mg
STANDARD_DEVIATION 0.000 • n=99 Participants
|
51.43 dose of medication, mg
STANDARD_DEVIATION 15.736 • n=107 Participants
|
48.00 dose of medication, mg
STANDARD_DEVIATION 13.984 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: Data not available on some participants.
A ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Total scores will range from 0 to 60. Higher scores indicate greater severity of depressive episodes.
Outcome measures
| Measure |
Levomilnacipran
n=26 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Changes of Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
|
-5.81 score on a scale
Standard Deviation 6.080
|
-6.97 score on a scale
Standard Deviation 7.632
|
SECONDARY outcome
Timeframe: Week 8Population: Data not available on some participants.
Remission was defined as \[\>or=50% reduction in MADRS score with MADRS \<or=10\] and response was defined as \[\>or=50% reduction in MADRS with MADRS \>10\]. Response rate included remission and response.
Outcome measures
| Measure |
Levomilnacipran
n=26 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Response Rate
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Data not available on some participants.
Remission was defined as \[\>or=50% reduction in MADRS score with MADRS \<or=10\]
Outcome measures
| Measure |
Levomilnacipran
n=26 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Remission Rate
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Number of words correctly recalled by the respondent is recorded. 1 point for each word correctly recalled. Total score range of 0-40. Higher scores mean better cognitive function.
Outcome measures
| Measure |
Levomilnacipran
n=29 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Changes in Neurocognition by Changes in Scores on Reyes Verbal Learning Test
|
2.28 score on a scale
Standard Deviation 5.694
|
2.90 score on a scale
Standard Deviation 5.255
|
SECONDARY outcome
Timeframe: Baseline to Week 8DSST measures working memory and visuospatial processing. 1 point for each object correctly substituted from number to each matched symbol. Total score range of 0-89. Higher scores mean better cognitive function.
Outcome measures
| Measure |
Levomilnacipran
n=29 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Changes in Neurocognition by Changes in Scores on Scores on Digit Symbol Substitution Test (DSST)
|
3.21 score on a scale
Standard Deviation 9.321
|
0.87 score on a scale
Standard Deviation 7.431
|
SECONDARY outcome
Timeframe: Baseline to Week 8CGI-S is a 7 point scale that assess the severity of illness and requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is used to assess the clinician's view of the patient's global functioning. Total score range of 0-7.
Outcome measures
| Measure |
Levomilnacipran
n=29 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Number of Subjects With Global Improvement in Scores on Clinical Global Impression Scale- Severity (CGI-S)
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Data not available for some participants.
CGI-I a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is used to assess the clinician's view of the patient's global functioning. Total score range of 0-7.
Outcome measures
| Measure |
Levomilnacipran
n=27 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Number of Subjects With General Improvement in Scores on Clinical Global Impression Scale- Improvement (CGI-I)
|
21 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Data not available for all subjects.
A questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score range of 0-48. A higher score indicates greater anxiety.
Outcome measures
| Measure |
Levomilnacipran
n=28 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Changes of Anxiety Symptoms in Scores on Hamilton Anxiety Rating Scale (HAM-A)
|
-3.89 score on a scale
Standard Deviation 4.969
|
-5.53 score on a scale
Standard Deviation 5.859
|
SECONDARY outcome
Timeframe: Baseline to Week 8A self-reported brief scale to assess impairment of work/school, social life and family and home. Total score range of 0-30. A higher score indicates greater impairment.
Outcome measures
| Measure |
Levomilnacipran
n=29 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Changes of Quality of Life in Scores on Sheehan Disability Scale (SDS) Total
|
-3.79 score on a scale
Standard Deviation 6.477
|
-0.10 score on a scale
Standard Deviation 8.126
|
SECONDARY outcome
Timeframe: Baseline to Week 8Self-Administered assessment measuring lack of motivation not attributable to diminished level of consciousness, cognitive impairment, or emotional distress. Total scores range from 0-54. Higher scores indicate greater apathy.
Outcome measures
| Measure |
Levomilnacipran
n=29 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Changes in Scores on Apathy Evaluation Scale (AES).
|
-2.07 score on a scale
Standard Deviation 8.689
|
-1.83 score on a scale
Standard Deviation 7.852
|
SECONDARY outcome
Timeframe: Baseline to Week 8ASEX is scale for sexual dysfunction to assess safety and tolerability of medication. Total scores range from 5-30. Higher scores indicate greater sexual dysfunction.
Outcome measures
| Measure |
Levomilnacipran
n=29 Participants
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=30 Participants
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Changes in Sexual Dysfunction by Changes in Scores on Arizona Sexual Experience Scale (ASEX)
|
-0.76 score on a scale
Standard Deviation 2.923
|
-0.30 score on a scale
Standard Deviation 4.829
|
Adverse Events
Levomilnacipran
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Quetiapine
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levomilnacipran
n=29 participants at risk
Levomilnacipran ER is switched from SSRI. Levomilnacipran ER: A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day, starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8.
|
Quetiapine
n=31 participants at risk
Quetiapine XR was added in addition to current SSRI. Quetiapine XR: Quetiapine XR was started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current SSRI.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.8%
4/29 • Screening to Week 9
|
12.9%
4/31 • Screening to Week 9
|
|
General disorders
Increase Appetite
|
0.00%
0/29 • Screening to Week 9
|
9.7%
3/31 • Screening to Week 9
|
|
General disorders
Weight Gain
|
3.4%
1/29 • Screening to Week 9
|
9.7%
3/31 • Screening to Week 9
|
|
General disorders
Weight Loss
|
3.4%
1/29 • Screening to Week 9
|
0.00%
0/31 • Screening to Week 9
|
|
Nervous system disorders
Headache
|
20.7%
6/29 • Screening to Week 9
|
6.5%
2/31 • Screening to Week 9
|
|
Nervous system disorders
Drowsiness
|
6.9%
2/29 • Screening to Week 9
|
38.7%
12/31 • Screening to Week 9
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • Screening to Week 9
|
3.2%
1/31 • Screening to Week 9
|
|
Nervous system disorders
Confusion
|
0.00%
0/29 • Screening to Week 9
|
6.5%
2/31 • Screening to Week 9
|
|
Renal and urinary disorders
Dysuria
|
6.9%
2/29 • Screening to Week 9
|
0.00%
0/31 • Screening to Week 9
|
|
General disorders
Dry Mouth
|
0.00%
0/29 • Screening to Week 9
|
3.2%
1/31 • Screening to Week 9
|
|
General disorders
Sweating
|
10.3%
3/29 • Screening to Week 9
|
0.00%
0/31 • Screening to Week 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place