Trial Outcomes & Findings for Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy (NCT NCT02058693)
NCT ID: NCT02058693
Last Updated: 2023-06-15
Results Overview
The CPFQ is a seven-item self-administered questionnaire with higher scores indicating increased impairment in cognitive and physical functioning; score range being 7-42.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)
Results posted on
2023-06-15
Participant Flow
Participant milestones
| Measure |
Group 1(A): Placebo/MSA
Phase I (3 weeks) placebo adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
|
Group 2(B): MSA/MSA
Phase I (3 weeks): mixed salts amphetamine, adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
|
|---|---|---|
|
Phase 1
STARTED
|
21
|
20
|
|
Phase 1
COMPLETED
|
16
|
16
|
|
Phase 1
NOT COMPLETED
|
5
|
4
|
|
Phase 2
STARTED
|
16
|
16
|
|
Phase 2
COMPLETED
|
16
|
14
|
|
Phase 2
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Group 1(A): Placebo/MSA
Phase I (3 weeks) placebo adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
|
Group 2(B): MSA/MSA
Phase I (3 weeks): mixed salts amphetamine, adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
|
|---|---|---|
|
Phase 1
Withdrawal by Subject
|
3
|
2
|
|
Phase 1
Adverse Event
|
0
|
1
|
|
Phase 1
Lack of Efficacy
|
1
|
0
|
|
Phase 1
Physician Decision
|
1
|
1
|
|
Phase 2
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy
Baseline characteristics by cohort
| Measure |
Group 1(A): Placebo/MSA
n=21 Participants
Phase I (3 weeks) placebo adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
mixed salts amphetamine: adjunctive to ADT
|
Group 2(B): MSA/MSA
n=20 Participants
mixed salts amphetamine, adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
mixed salts amphetamine: adjunctive to ADT
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)Population: Subjects completing all seven visits and administered the CPFQ. Some subjects completing seven visits were not administered the CPFQ in error.
The CPFQ is a seven-item self-administered questionnaire with higher scores indicating increased impairment in cognitive and physical functioning; score range being 7-42.
Outcome measures
| Measure |
Group 1(A): Placebo/MSA
n=10 Participants
Phase I (3 weeks) placebo adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
|
Group 2(B): MSA/MSA
n=13 Participants
Phase I (3 weeks): mixed salts amphetamine, adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
|
|---|---|---|
|
Change in Scores on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)
Baseline (V2)
|
27.5 Scores on a scale
Standard Deviation 8.4896
|
29 Scores on a scale
Standard Deviation 5.33
|
|
Change in Scores on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)
End Phase I (V5; W3)
|
22.6 Scores on a scale
Standard Deviation 7.78
|
25 Scores on a scale
Standard Deviation 6.45
|
|
Change in Scores on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)
End Phase II (V8; W6)
|
16 Scores on a scale
Standard Deviation 4.69
|
21 Scores on a scale
Standard Deviation 5.73
|
SECONDARY outcome
Timeframe: Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)The group treated with mixed salt amphetamine (MSA) adjunctive to antidepressant therapy (ADT) will show a greater mean change from baseline to endpoint as compared to the group treated with placebo (PBO) adjunctive to ADT as measure by the change ion the MADRS scores. The MADRS is clinician-rated and consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology. The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression," 20 to 34 indicates "moderate depression," a score of 35 and greater indicates "severe depression." There is evidence that an improvement of two points or more on the MADRS is considered clinically relevant.
Outcome measures
| Measure |
Group 1(A): Placebo/MSA
n=11 Participants
Phase I (3 weeks) placebo adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
|
Group 2(B): MSA/MSA
n=13 Participants
Phase I (3 weeks): mixed salts amphetamine, adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
|
|---|---|---|
|
Change in Scores of the Montgomery Asberg Depression Rating Scale (MADRS)
Baseline (V2)
|
24.18 Scores on a scale
Standard Deviation 6.54
|
27 Scores on a scale
Standard Deviation 6.2
|
|
Change in Scores of the Montgomery Asberg Depression Rating Scale (MADRS)
End of Phase I (V5; W3)
|
11.55 Scores on a scale
Standard Deviation 7.67
|
18.31 Scores on a scale
Standard Deviation 10.24
|
|
Change in Scores of the Montgomery Asberg Depression Rating Scale (MADRS)
End of Phase II (V8; W6)
|
7.10 Scores on a scale
Standard Deviation 4.76
|
10.17 Scores on a scale
Standard Deviation 8.33
|
SECONDARY outcome
Timeframe: Baseline (Visit 2); End Phase I (Visit 5, Week 3): End Phase II (Visit 8, Week 6)The group with mixed salt amphetamine (MSA) adjunctive to antidepressant therapy (ADT) will show statistically significant improvement in core residual symptoms of major depressive disorder (MDD) extant on monotherapy ADT as measured by the Quick Inventory of Depressive Symptomatology Self Report 16. 16 items comprising 9 domains; each domain is scored from 0 to 3, with higher scores reflecting greater psychopathology. Total scores range from 0 to 27. Scoring procedure is to include ONLY the highest score on among the 4 sleep items (items 1 to 4); include ONLY the highest score among the 4 weight items (items 6 to 9); include ONLY the highest score on either of the 2 psychomotor items (15 and 16). The scores for these 3 domains are then added to the scores (0-3) for each of the 6 MDD symptom domains for a total score of 0-27.
Outcome measures
| Measure |
Group 1(A): Placebo/MSA
n=11 Participants
Phase I (3 weeks) placebo adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
|
Group 2(B): MSA/MSA
n=13 Participants
Phase I (3 weeks): mixed salts amphetamine, adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT
|
|---|---|---|
|
Change in Scores on the Quick Inventory of Depressive Symptomatology Self Report 16 (QIDS-SR-16)
Baseline (V2; W1)
|
12.5 Scores on a scale
Standard Deviation 3.8
|
14 Scores on a scale
Standard Deviation 4.5
|
|
Change in Scores on the Quick Inventory of Depressive Symptomatology Self Report 16 (QIDS-SR-16)
End of Phase I (V5; W3)
|
7.8 Scores on a scale
Standard Deviation 3.22
|
8.7 Scores on a scale
Standard Deviation 5.6
|
|
Change in Scores on the Quick Inventory of Depressive Symptomatology Self Report 16 (QIDS-SR-16)
End of Phase II (V7; W6)
|
5 Scores on a scale
Standard Deviation 2.2
|
5.3 Scores on a scale
Standard Deviation 4.4
|
Adverse Events
Group 1(A): Placebo/MSA
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2(B): MSA/MSA
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1(A): Placebo/MSA
n=16 participants at risk
Phase I (3 weeks) placebo adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT (as in Phase I).
mixed salts amphetamine: adjunctive to ADT
|
Group 2(B): MSA/MSA
n=16 participants at risk
Phase I (3 weeks) mixed salts amphetamine adjunctive to Anti-Depressant Therapy (ADT). The total daily dosing of the concurrent ADT will be as follow: escitalopram 10-40 mg; Fluoxetine 20-80 mg; paroxetine CR (controlled release) 25-100 mg (paroxetine 20-80 mg may be substituted if paroxetine CR is not available); sertraline 100-400 mg; venlafaxine XR (extended release) 150-600 mg; desvenlafaxine 50-200 mg; citalopram 20-80 mg; or duloxetine 60-180 mg; buproprion 150-450 mg; mirtazapine 15-45 mg, tricyclics (standard dosing, individually per label instructions).
Phase II (3 weeks) mixed salts amphetamine adjunctive to ADT (as in Phase I).
mixed salts amphetamine: adjunctive to ADT
|
|---|---|---|
|
Nervous system disorders
Agitation
|
12.5%
2/16 • Number of events 2 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
12.5%
2/16 • Number of events 2 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Product Issues
Bad taste
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
General disorders
Blurred vision
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
General disorders
Body ache
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Infections and infestations
Conjunctivitis
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Gastrointestinal disorders
Decreased appetite
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
General disorders
Dry mouth
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
12.5%
2/16 • Number of events 2 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
General disorders
Headache
|
25.0%
4/16 • Number of events 4 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
25.0%
4/16 • Number of events 4 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
General disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Cardiac disorders
Mild heart tremor
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Psychiatric disorders
Racy feelings
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Gastrointestinal disorders
Acid reflux
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Injury, poisoning and procedural complications
Injury: slip and fall, bruising
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
General disorders
Sweating
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
General disorders
Tinnitus
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
2/16 • Number of events 2 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
General disorders
Vertigo
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Immune system disorders
Watery, itchy eyes
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
General disorders
Weight loss
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
|
Psychiatric disorders
Word finding
|
0.00%
0/16 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
6.2%
1/16 • Number of events 1 • AE data were collected over the seven weeks of the trial.
Definition does not differ from the clinicaltrials.gov definitions. Adverse event data were collected by group but not by phase in this trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place