Trial Outcomes & Findings for SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder (NCT NCT01435759)
NCT ID: NCT01435759
Last Updated: 2021-06-09
Results Overview
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1197 participants
Primary outcome timeframe
Augmentation Baseline (Week 8) to Week 16
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
Antidepressant + Single-blind Placebo
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily single-blind placebo (matching SPD489).
|
Antidepressant + Double-blind Placebo
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
|
Antidepressant + Double-blind SPD489 10mg
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
|
Antidepressant + Double-blind SPD489 30mg
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
|
Antidepressant + Double-blind SPD489 50mg
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
|
Antidepressant + Double-blind SPD489 70mg
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
|
|---|---|---|---|---|---|---|
|
Antidepressant Lead-in Phase
STARTED
|
1197
|
0
|
0
|
0
|
0
|
0
|
|
Antidepressant Lead-in Phase
COMPLETED
|
855
|
0
|
0
|
0
|
0
|
0
|
|
Antidepressant Lead-in Phase
NOT COMPLETED
|
342
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Phase
STARTED
|
463
|
78
|
78
|
78
|
78
|
80
|
|
Double-blind Phase
COMPLETED
|
397
|
71
|
71
|
69
|
69
|
71
|
|
Double-blind Phase
NOT COMPLETED
|
66
|
7
|
7
|
9
|
9
|
9
|
Reasons for withdrawal
| Measure |
Antidepressant + Single-blind Placebo
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily single-blind placebo (matching SPD489).
|
Antidepressant + Double-blind Placebo
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
|
Antidepressant + Double-blind SPD489 10mg
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
|
Antidepressant + Double-blind SPD489 30mg
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
|
Antidepressant + Double-blind SPD489 50mg
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
|
Antidepressant + Double-blind SPD489 70mg
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
|
|---|---|---|---|---|---|---|
|
Antidepressant Lead-in Phase
Adverse Event
|
40
|
0
|
0
|
0
|
0
|
0
|
|
Antidepressant Lead-in Phase
Protocol Violation
|
16
|
0
|
0
|
0
|
0
|
0
|
|
Antidepressant Lead-in Phase
Withdrawal by Subject
|
74
|
0
|
0
|
0
|
0
|
0
|
|
Antidepressant Lead-in Phase
Lost to Follow-up
|
83
|
0
|
0
|
0
|
0
|
0
|
|
Antidepressant Lead-in Phase
Met BP or Pulse Withdrawal Criteria
|
10
|
0
|
0
|
0
|
0
|
0
|
|
Antidepressant Lead-in Phase
Other
|
119
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Phase
Adverse Event
|
7
|
0
|
1
|
1
|
1
|
3
|
|
Double-blind Phase
Protocol Violation
|
2
|
0
|
1
|
2
|
0
|
1
|
|
Double-blind Phase
Withdrawal by Subject
|
17
|
4
|
3
|
4
|
2
|
2
|
|
Double-blind Phase
Lost to Follow-up
|
31
|
1
|
2
|
0
|
3
|
3
|
|
Double-blind Phase
Met BP or Pulse Withdrawal Criteria
|
1
|
0
|
0
|
0
|
3
|
0
|
|
Double-blind Phase
Other
|
8
|
2
|
0
|
2
|
0
|
0
|
Baseline Characteristics
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Antidepressant + Double-blind Placebo
n=78 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
|
Antidepressant + Double-blind SPD489 10mg
n=77 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
|
Antidepressant + Double-blind SPD489 30mg
n=76 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
|
Antidepressant + Double-blind SPD489 50mg
n=78 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
|
Antidepressant + Double-blind SPD489 70mg
n=80 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
|
Total
n=389 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.7 Years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
39.1 Years
STANDARD_DEVIATION 11.83 • n=7 Participants
|
43.4 Years
STANDARD_DEVIATION 12.06 • n=5 Participants
|
43.8 Years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
41.5 Years
STANDARD_DEVIATION 10.81 • n=21 Participants
|
42.3 Years
STANDARD_DEVIATION 11.61 • n=10 Participants
|
|
Age, Customized
18-55
|
69 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
332 Participants
n=10 Participants
|
|
Age, Customized
56-65
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
264 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
125 Participants
n=10 Participants
|
|
Region of Enrollment
ARGENTINA
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
|
Region of Enrollment
AUSTRALIA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Region of Enrollment
CHILE
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
UNITED STATES
|
72 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
333 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Augmentation Baseline (Week 8) to Week 16Population: Dose Response Evaluable Set (DRES): All randomized subjects who had at least 1 valid primary efficacy measurement (MADRS total score) during the Dose Maintenance Period (Weeks 11-16) while on the target dose level of investigational product.
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16.
Outcome measures
| Measure |
Antidepressant + Double-blind Placebo
n=72 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
|
Antidepressant + Double-blind SPD489 10mg
n=71 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
|
Antidepressant + Double-blind SPD489 30mg
n=69 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
|
Antidepressant + Double-blind SPD489 50mg
n=66 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
|
Antidepressant + Double-blind SPD489 70mg
n=71 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
|
|---|---|---|---|---|---|
|
Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)
|
-5.4 units on a scale
Interval -7.2 to -3.5
|
-6.7 units on a scale
Interval -8.6 to -4.9
|
-5.3 units on a scale
Interval -7.1 to -3.4
|
-6.1 units on a scale
Interval -8.1 to -4.1
|
-6.3 units on a scale
Interval -8.2 to -4.4
|
SECONDARY outcome
Timeframe: From Augmentation Baseline (Week 8) to Week 16Population: Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.
Outcome measures
| Measure |
Antidepressant + Double-blind Placebo
n=67 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
|
Antidepressant + Double-blind SPD489 10mg
n=68 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
|
Antidepressant + Double-blind SPD489 30mg
n=65 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
|
Antidepressant + Double-blind SPD489 50mg
n=51 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
|
Antidepressant + Double-blind SPD489 70mg
n=63 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
|
|---|---|---|---|---|---|
|
Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
|
-0.2 mmHg
Standard Deviation 9.55
|
0.2 mmHg
Standard Deviation 8.58
|
0.5 mmHg
Standard Deviation 9.17
|
3.5 mmHg
Standard Deviation 7.82
|
2.6 mmHg
Standard Deviation 10.55
|
SECONDARY outcome
Timeframe: From Augmentation Baseline (Week 8) to Week 16Population: Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.
Outcome measures
| Measure |
Antidepressant + Double-blind Placebo
n=67 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
|
Antidepressant + Double-blind SPD489 10mg
n=68 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
|
Antidepressant + Double-blind SPD489 30mg
n=65 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
|
Antidepressant + Double-blind SPD489 50mg
n=51 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
|
Antidepressant + Double-blind SPD489 70mg
n=63 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
|
|---|---|---|---|---|---|
|
Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
|
-0.1 mmHg
Standard Deviation 6.69
|
-0.9 mmHg
Standard Deviation 6.64
|
-0.1 mmHg
Standard Deviation 7.39
|
2.8 mmHg
Standard Deviation 6.58
|
1.9 mmHg
Standard Deviation 7.45
|
SECONDARY outcome
Timeframe: From Augmentation Baseline (Week 8) to Week 16Population: Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.
Outcome measures
| Measure |
Antidepressant + Double-blind Placebo
n=67 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
|
Antidepressant + Double-blind SPD489 10mg
n=68 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
|
Antidepressant + Double-blind SPD489 30mg
n=65 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
|
Antidepressant + Double-blind SPD489 50mg
n=51 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
|
Antidepressant + Double-blind SPD489 70mg
n=63 Participants
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
|
|---|---|---|---|---|---|
|
Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16
|
-0.8 bpm
Standard Deviation 9.95
|
0.8 bpm
Standard Deviation 7.32
|
5.3 bpm
Standard Deviation 8.08
|
4.0 bpm
Standard Deviation 9.80
|
6.0 bpm
Standard Deviation 11.25
|
Adverse Events
Antidepressant + Double-blind Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Antidepressant + Double-blind SPD489 10mg
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Antidepressant + Double-blind SPD489 30mg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Antidepressant + Double-blind SPD489 50mg
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Antidepressant + Double-blind SPD489 70mg
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antidepressant + Double-blind Placebo
n=78 participants at risk
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
|
Antidepressant + Double-blind SPD489 10mg
n=77 participants at risk
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
|
Antidepressant + Double-blind SPD489 30mg
n=76 participants at risk
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
|
Antidepressant + Double-blind SPD489 50mg
n=78 participants at risk
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
|
Antidepressant + Double-blind SPD489 70mg
n=80 participants at risk
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/78
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
0.00%
0/77
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
0.00%
0/76
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
0.00%
0/78
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.2%
1/80 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
Other adverse events
| Measure |
Antidepressant + Double-blind Placebo
n=78 participants at risk
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
|
Antidepressant + Double-blind SPD489 10mg
n=77 participants at risk
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
|
Antidepressant + Double-blind SPD489 30mg
n=76 participants at risk
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
|
Antidepressant + Double-blind SPD489 50mg
n=78 participants at risk
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
|
Antidepressant + Double-blind SPD489 70mg
n=80 participants at risk
Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
4/78 • Number of events 5
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.6%
2/77 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
3.9%
3/76 • Number of events 3
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.6%
2/78 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
6.2%
5/80 • Number of events 5
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
1/78 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.6%
2/77 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.6%
2/76 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
12.8%
10/78 • Number of events 10
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
12.5%
10/80 • Number of events 10
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
6.5%
5/77 • Number of events 5
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
7.9%
6/76 • Number of events 6
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.3%
1/78 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
7.5%
6/80 • Number of events 7
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
General disorders
Fatigue
|
1.3%
1/78 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
0.00%
0/77
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.6%
2/76 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.3%
1/78 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
5.0%
4/80 • Number of events 4
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Infections and infestations
Influenza
|
2.6%
2/78 • Number of events 3
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.3%
1/77 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
5.3%
4/76 • Number of events 4
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
5.1%
4/78 • Number of events 5
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.2%
1/80 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/78
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
6.5%
5/77 • Number of events 5
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
5.3%
4/76 • Number of events 5
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.6%
2/78 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
8.8%
7/80 • Number of events 8
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/78
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
3.9%
3/77 • Number of events 3
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
3.9%
3/76 • Number of events 3
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
5.1%
4/78 • Number of events 4
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
3.8%
3/80 • Number of events 3
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
5/78 • Number of events 5
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.3%
1/77 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.6%
2/76 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.3%
1/78 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.5%
2/80 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Investigations
Blood pressure increased
|
0.00%
0/78
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.3%
1/77 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
0.00%
0/76
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
3.8%
3/78 • Number of events 3
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
5.0%
4/80 • Number of events 4
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
1/78 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
5.2%
4/77 • Number of events 4
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
6.6%
5/76 • Number of events 6
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
6.4%
5/78 • Number of events 5
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
5.0%
4/80 • Number of events 6
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Nervous system disorders
Dizziness
|
2.6%
2/78 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.6%
2/77 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.6%
2/76 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
6.4%
5/78 • Number of events 5
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.2%
1/80 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Nervous system disorders
Headache
|
12.8%
10/78 • Number of events 12
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
9.1%
7/77 • Number of events 8
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
6.6%
5/76 • Number of events 9
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
3.8%
3/78 • Number of events 5
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
10.0%
8/80 • Number of events 9
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Psychiatric disorders
Bruxism
|
1.3%
1/78 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
0.00%
0/77
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.3%
1/76 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
5.1%
4/78 • Number of events 4
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
7.5%
6/80 • Number of events 7
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Psychiatric disorders
Insomnia
|
2.6%
2/78 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
9.1%
7/77 • Number of events 9
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
2.6%
2/76 • Number of events 2
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
10.3%
8/78 • Number of events 10
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
11.2%
9/80 • Number of events 11
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
1/78 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
5.2%
4/77 • Number of events 4
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
0.00%
0/76
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
1.3%
1/78 • Number of events 1
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
3.8%
3/80 • Number of events 3
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER