A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
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| ClinicalTrials.gov Identifier: NCT02085135 |
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Recruitment Status :
Completed
First Posted : March 12, 2014
Results First Posted : March 27, 2019
Last Update Posted : August 14, 2019
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Sponsor:
Alkermes, Inc.
Information provided by (Responsible Party):
Alkermes, Inc.
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Major Depressive Disorder |
| Intervention |
Drug: ALKS 5461 |
| Enrollment | 66 |
Participant Flow
| Recruitment Details | 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. |
| Pre-assignment Details |
| Arm/Group Title | 1-Week Titration | 2-Week Titration |
|---|---|---|
 Arm/Group Description |
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period | ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period |
| Period Title: Overall Study | ||
| Started | 34 | 32 |
| Completed | 23 | 23 |
| Not Completed | 11 | 9 |
| Reason Not Completed | ||
| Adverse Event | 4 | 7 |
| Lost to Follow-up | 2 | 2 |
| Withdrawal by Subject | 3 | 0 |
| Lack of Efficacy | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | 1-Week Titration | 2-Week Titration | Total | |
|---|---|---|---|---|
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Arm/Group Description |
ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period | ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period | Total of all reporting groups | |
| Overall Number of Baseline Participants | 34 | 32 | 66 | |
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Baseline Analysis Population Description |
All subjects who received at least 1 dose of study drug
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 34 participants | 32 participants | 66 participants | |
| 48.7 (12.6) | 50.8 (11.3) | 49.7 (53) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 34 participants | 32 participants | 66 participants | |
| Female |
20 58.8%
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21 65.6%
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41 62.1%
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| Male |
14 41.2%
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11 34.4%
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25 37.9%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 34 participants | 32 participants | 66 participants | |
| Hispanic or Latino |
2 5.9%
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5 15.6%
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7 10.6%
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| Not Hispanic or Latino |
32 94.1%
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27 84.4%
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59 89.4%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 34 participants | 32 participants | 66 participants | |
| American Indian or Alaska Native |
1 2.9%
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1 3.1%
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2 3.0%
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| Asian |
0 0.0%
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1 3.1%
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1 1.5%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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1 3.1%
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1 1.5%
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| Black or African American |
8 23.5%
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6 18.8%
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14 21.2%
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| White |
24 70.6%
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23 71.9%
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47 71.2%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
1 2.9%
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0 0.0%
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1 1.5%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 34 participants | 32 participants | 66 participants |
| Canada |
1 2.9%
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0 0.0%
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1 1.5%
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| United States |
33 97.1%
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32 100.0%
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65 98.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
| Name/Title: | Eva Stroynowski |
| Organization: | Alkermes |
| Phone: | 781-609-7000 |
| EMail: | eva.stroynowski@alkermes.com |
| Responsible Party: | Alkermes, Inc. |
| ClinicalTrials.gov Identifier: | NCT02085135 |
| Other Study ID Numbers: |
ALK5461-210 |
| First Submitted: | March 7, 2014 |
| First Posted: | March 12, 2014 |
| Results First Submitted: | March 1, 2019 |
| Results First Posted: | March 27, 2019 |
| Last Update Posted: | August 14, 2019 |