Major Depressive Disorder
Conditions
Keywords
depression, major depressive disorder, Alkermes, ALKS 5461, samidorphan, buprenorphine
Brief summary
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
Interventions
DRUGALKS 5461
Sublingual tablet taken once daily
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index of 18-40 kg/m2 * Have a diagnosis of MDD * Have a current major depressive episode (MDE) lasting 8 weeks to 24 months * Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks * Have an inadequate response to current antidepressant treatment * Agree to use an approved method of birth control for the duration of the study * Additional criteria may apply
Exclusion criteria
* Currently pregnant or breastfeeding * History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV) * Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE * Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days * Have received electroconvulsive therapy treatment within the last 5 years * Have attempted suicide within the past 2 years * Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) * Have had a significant blood loss or blood donation with 60 days of screening * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With Adverse Events (AEs) | 8 weeks |
Countries
Canada, United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 1-Week Titration ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 1-week titration period | 34 |
| 2-Week Titration ALKS 5461: Sublingual tablet taken once daily in ascending doses over a 2-week titration period | 32 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 7 |
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | 1-Week Titration | Total | 2-Week Titration |
|---|---|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 12.6 | 49.7 years STANDARD_DEVIATION 53 | 50.8 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 7 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 59 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 47 Participants | 23 Participants |
| Region of Enrollment Canada | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 33 Participants | 65 Participants | 32 Participants |
| Sex: Female, Male Female | 20 Participants | 41 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 25 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 |
| other Total, other adverse events | 23 / 34 | 28 / 32 |
| serious Total, serious adverse events | 0 / 34 | 0 / 32 |
Outcome results
Primary
Number of Subjects With Adverse Events (AEs)
Time frame: 8 weeks
Population: Number of subjects who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1-Week Titration | Number of Subjects With Adverse Events (AEs) | 27 Participants |
| 2-Week Titration | Number of Subjects With Adverse Events (AEs) | 28 Participants |