Trial Outcomes & Findings for A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD) (NCT NCT02085135)
NCT ID: NCT02085135
Last Updated: 2019-08-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-08-14
Participant Flow
Subjects were diagnosed with major depressive disorder (MDD) and had an inadequate response to 1 or 2 adequate courses of treatment with a commercially available antidepressant therapy (ADT) during the current major depressive episode (MDE). All subjects continued ADT for the duration of the study.
Participant milestones
| Measure |
1-Week Titration
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period
|
2-Week Titration
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
| Measure |
1-Week Titration
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period
|
2-Week Titration
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
Baseline Characteristics
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
1-Week Titration
n=34 Participants
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period
|
2-Week Titration
n=32 Participants
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Number of subjects who received at least 1 dose of study drug.
Outcome measures
| Measure |
1-Week Titration
n=34 Participants
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period
|
2-Week Titration
n=32 Participants
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period
|
|---|---|---|
|
Number of Subjects With Adverse Events (AEs)
|
27 Participants
|
28 Participants
|
Adverse Events
1-Week Titration
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
2-Week Titration
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1-Week Titration
n=34 participants at risk
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period
|
2-Week Titration
n=32 participants at risk
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
17.6%
6/34 • Number of events 6 • Up to 8 weeks
|
34.4%
11/32 • Number of events 12 • Up to 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
26.5%
9/34 • Number of events 14 • Up to 8 weeks
|
21.9%
7/32 • Number of events 7 • Up to 8 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
8.8%
3/34 • Number of events 3 • Up to 8 weeks
|
25.0%
8/32 • Number of events 8 • Up to 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
20.6%
7/34 • Number of events 7 • Up to 8 weeks
|
3.1%
1/32 • Number of events 1 • Up to 8 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.9%
2/34 • Number of events 2 • Up to 8 weeks
|
0.00%
0/32 • Up to 8 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
2/34 • Number of events 2 • Up to 8 weeks
|
0.00%
0/32 • Up to 8 weeks
|
|
Nervous system disorders
Headache
|
14.7%
5/34 • Number of events 12 • Up to 8 weeks
|
12.5%
4/32 • Number of events 4 • Up to 8 weeks
|
|
Nervous system disorders
Somnolence
|
8.8%
3/34 • Number of events 3 • Up to 8 weeks
|
15.6%
5/32 • Number of events 7 • Up to 8 weeks
|
|
Nervous system disorders
Dizziness
|
8.8%
3/34 • Number of events 3 • Up to 8 weeks
|
6.2%
2/32 • Number of events 2 • Up to 8 weeks
|
|
Nervous system disorders
Dysgeusia
|
11.8%
4/34 • Number of events 4 • Up to 8 weeks
|
3.1%
1/32 • Number of events 1 • Up to 8 weeks
|
|
Nervous system disorders
Sedation
|
0.00%
0/34 • Up to 8 weeks
|
12.5%
4/32 • Number of events 4 • Up to 8 weeks
|
|
Psychiatric disorders
Insomnia
|
11.8%
4/34 • Number of events 4 • Up to 8 weeks
|
12.5%
4/32 • Number of events 4 • Up to 8 weeks
|
|
General disorders
Fatigue
|
17.6%
6/34 • Number of events 6 • Up to 8 weeks
|
3.1%
1/32 • Number of events 1 • Up to 8 weeks
|
|
General disorders
Irritability
|
0.00%
0/34 • Up to 8 weeks
|
6.2%
2/32 • Number of events 2 • Up to 8 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.9%
2/34 • Number of events 2 • Up to 8 weeks
|
6.2%
2/32 • Number of events 3 • Up to 8 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/34 • Up to 8 weeks
|
6.2%
2/32 • Number of events 2 • Up to 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.
- Publication restrictions are in place
Restriction type: OTHER