Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titration Schedule 1 | Experimental |
| |
| Titration Schedule 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 5461 | Drug | Sublingual tablet taken once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events (AEs) | 8 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sanjeev Pathak, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Jacksonville | Florida | 32256 | United States | ||
| Alkermes Investigational Site |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1-Week Titration | ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period |
| FG001 | 2-Week Titration | ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Orlando |
| Florida |
| 32806 |
| United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30308 | United States |
| Alkermes Investigational Site | Saint Charles | Missouri | 63304 | United States |
| Alkermes Investigational Site | Staten Island | New York | 10305 | United States |
| Alkermes Investigational Site | Dayton | Ohio | 45417 | United States |
| Alkermes Investigational Site | Allentown | Pennsylvania | 18104 | United States |
| Alkermes Investigational Site | Bellevue | Washington | 98007 | United States |
| Alkermes Investigational Site | Halifax | Nova Scotia | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All subjects who received at least 1 dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1-Week Titration | ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period |
| BG001 | 2-Week Titration | ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Adverse Events (AEs) | Number of subjects who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
Up to 8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1-Week Titration | ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period | 0 | 34 | 0 | 34 | 23 | 34 |
| EG001 | 2-Week Titration | ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period | 0 | 32 | 0 | 32 | 28 | 32 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Stroynowski | Alkermes | 781-609-7000 | eva.stroynowski@alkermes.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C000618349 | ALKS 5461 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|