Trial Outcomes & Findings for Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression (NCT NCT03993457)
NCT ID: NCT03993457
Last Updated: 2023-04-18
Results Overview
The primary study endpoint will be remission rates based on the 16-items Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR), which will be extracted from the 30-item Inventory of Depressive Symptomatology (IDS-SR). The QIDS-SR score ranges from 0-27. A score of 5 or less represents remission.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
1 year
Results posted on
2023-04-18
Participant Flow
Participant milestones
| Measure |
CRP<1, CRP Consistent Antidepressant Selection
Participants with CRP\<1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Consistent Antidepressant Selection
Participants with CRP\> or equal to 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP<1, CRP Inconsistent Antidepressant Selection
Participants with CRP\< 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection
Participants with CRP\> or equal to 1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
1
|
4
|
|
Overall Study
COMPLETED
|
4
|
2
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression
Baseline characteristics by cohort
| Measure |
CRP<1, CRP Consistent Antidepressant Selection
n=4 Participants
Participants with CRP\<1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Consistent Antidepressant
n=2 Participants
Participants with CRP\> or equal to 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP<1, CRP Inconsistent Antidepressant Selection
n=1 Participants
Participants with CRP\< 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection
n=4 Participants
Participants with CRP\> or equal to 1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
Total
n=11 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 15.2 • n=99 Participants
|
33.5 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
25 years
STANDARD_DEVIATION 0 • n=206 Participants
|
25.7 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
33.8 years
STANDARD_DEVIATION 13.2 • n=31 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Gender · Unknown/Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
11 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe primary study endpoint will be remission rates based on the 16-items Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR), which will be extracted from the 30-item Inventory of Depressive Symptomatology (IDS-SR). The QIDS-SR score ranges from 0-27. A score of 5 or less represents remission.
Outcome measures
| Measure |
CRP<1, CRP Consistent Antidepressant Selection
n=4 Participants
Participants with CRP\<1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Consistent Antidepressant Selection
n=2 Participants
Participants with CRP\> or equal to 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP<1, CRP Inconsistent Antidepressant Selection
n=1 Participants
Participants with CRP\< 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection
n=4 Participants
Participants with CRP\> or equal to 1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
|---|---|---|---|---|
|
Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Remission Rates in Patients With MDD.
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 12 weeksImprovement in social and occupational functioning will be measured with the 5-item self-administered Work and Social Adjustment Scale (WSAS). The WSAS total score ranges from 0-40. Lower scores are better.
Outcome measures
| Measure |
CRP<1, CRP Consistent Antidepressant Selection
n=4 Participants
Participants with CRP\<1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Consistent Antidepressant Selection
n=2 Participants
Participants with CRP\> or equal to 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP<1, CRP Inconsistent Antidepressant Selection
n=1 Participants
Participants with CRP\< 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection
n=2 Participants
Participants with CRP\> or equal to 1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
|---|---|---|---|---|
|
Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Improving Social and Occupational Functioning.
|
-17.3 score on a scale
Standard Deviation 8.0
|
-24.4 score on a scale
Standard Deviation 20.3
|
-18.0 score on a scale
Standard Deviation 0
|
-23.5 score on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: 1 yearSide effects will be assessed using the 3-item self-administered Frequency, Intensity, and Burden of Side Effects (FIBSER). Each item is scored on a scale from 0-6. Items 1 and 2 (Frequency \& Intensity respectively) are to provide information to the clinician, but they are not used in the scoring.The score that is used comes only from Item 3 - Burden. Lower scores represents lower burden.
Outcome measures
| Measure |
CRP<1, CRP Consistent Antidepressant Selection
n=4 Participants
Participants with CRP\<1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Consistent Antidepressant Selection
n=2 Participants
Participants with CRP\> or equal to 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP<1, CRP Inconsistent Antidepressant Selection
n=1 Participants
Participants with CRP\< 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection
n=2 Participants
Participants with CRP\> or equal to 1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
|---|---|---|---|---|
|
Adverse Antidepressant Treatment Effects on CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection
|
.25 score on a scale
Standard Deviation .5
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Some participants did not have a venous blood CRP conducted.
Capillary blood CRP levels will be compared with those obtained using venous blood obtained via venipuncture. Outcome will be number of participants whose capillary blood CRP levels and venous blood CRPT levels match in terms of \<1 vs. \>=1.
Outcome measures
| Measure |
CRP<1, CRP Consistent Antidepressant Selection
n=2 Participants
Participants with CRP\<1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Consistent Antidepressant Selection
Participants with CRP\> or equal to 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP<1, CRP Inconsistent Antidepressant Selection
n=1 Participants
Participants with CRP\< 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection
n=4 Participants
Participants with CRP\> or equal to 1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
|---|---|---|---|---|
|
Optional Sub-study. Validity and Reliability of Capillary Blood CRP Measurement
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
CRP<1, CRP Consistent Antidepressant Selection
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CRP> or Equal to 1, CRP Consistent Antidepressant Selection
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CRP<1, CRP Inconsistent Antidepressant Selection
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CRP<1, CRP Consistent Antidepressant Selection
n=4 participants at risk
Participants with CRP\<1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Consistent Antidepressant Selection
n=2 participants at risk
Participants with CRP\> or equal to 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP<1, CRP Inconsistent Antidepressant Selection
n=1 participants at risk
Participants with CRP\< 1 will be prescribed bupropion XL
Bupropion: Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
|
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection
n=4 participants at risk
Participants with CRP\> or equal to 1 will be prescribed escitalopram
Escitalopram: Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.00%
0/4 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
0.00%
0/1 • 12 weeks
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/4 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
0.00%
0/1 • 12 weeks
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
diarrhea
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
0.00%
0/1 • 12 weeks
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
lower back pain
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
0.00%
0/1 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Psychiatric disorders
worsening anxiety symptoms
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
0.00%
0/1 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Psychiatric disorders
night insomnia
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
0.00%
0/1 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Nervous system disorders
headaches
|
50.0%
2/4 • Number of events 2 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
0.00%
0/1 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
mouth sores
|
0.00%
0/4 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
100.0%
1/1 • Number of events 1 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Gastrointestinal disorders
epigastric pain
|
0.00%
0/4 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
100.0%
1/1 • Number of events 1 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Cardiac disorders
heart palpitations
|
50.0%
2/4 • Number of events 2 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
0.00%
0/1 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Gastrointestinal disorders
heartburn
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
0.00%
0/1 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Gastrointestinal disorders
upset stomach
|
0.00%
0/4 • 12 weeks
|
50.0%
1/2 • Number of events 1 • 12 weeks
|
0.00%
0/1 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place