Major Depressive Disorder
Conditions
Brief summary
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
Interventions
DRUGALKS 5461
Sublingual tablet, taken daily
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Agree to use an approved method of contraception for the duration of the study * Have the potential to safely benefit from the administration of ALKS 5461 * Have a diagnosis of major depressive disorder (MDD) * Additional criteria may apply
Exclusion criteria
* Have a positive test for drugs of abuse * Currently pregnant or breastfeeding * Have a current primary Axis-I disorder other than MDD * Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days * Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime * 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 within the past 60 days * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs) | Up to 56 weeks |
Countries
Australia, Bulgaria, Canada, Germany, Hungary, Poland, Puerto Rico, United States
Participant flow
Recruitment details
Subjects were entered into the study in one of 3 ways, based upon previous experience with a prior ALKS 5461 study: Subjects continuing from a prior ALKS 5461 study; Subjects who participated in the prospective lead-in for a prior ALKS 5461 study, but did not meet the entrance criteria; Subjects who did not participate in a prior ALKS 5461 study.
Pre-assignment details
All subjects received ALKS 5461 during the course of the study as an adjunctive treatment for major depressive disorder. In addition all subjects were treated with background antidepressant therapy prescribed by the investigator.
Participants by arm
| Arm | Count |
|---|---|
| ALKS 5461 ALKS 5461 adjunctive treatment | 1,485 |
| Total | 1,485 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 158 |
| Overall Study | Failure to meet eligibility criteria | 14 |
| Overall Study | Lack of Efficacy | 62 |
| Overall Study | Lost to Follow-up | 151 |
| Overall Study | Non-compliance with study drug | 18 |
| Overall Study | Other | 45 |
| Overall Study | Physician Decision | 17 |
| Overall Study | Pregnancy | 3 |
| Overall Study | Protocol Violation | 38 |
| Overall Study | Withdrawal by Subject | 238 |
Baseline characteristics
| Characteristic | ALKS 5461 |
|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 12.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 197 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1288 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 28 Participants |
| Race (NIH/OMB) Black or African American | 362 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 8 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1080 Participants |
| Region of Enrollment Australia | 35 participants |
| Region of Enrollment Bulgaria | 88 participants |
| Region of Enrollment Canada | 54 participants |
| Region of Enrollment Germany | 66 participants |
| Region of Enrollment Hungary | 5 participants |
| Region of Enrollment Poland | 33 participants |
| Region of Enrollment United States | 1204 participants |
| Sex: Female, Male Female | 964 Participants |
| Sex: Female, Male Male | 521 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 1,485 |
| other Total, other adverse events | 1,124 / 1,485 |
| serious Total, serious adverse events | 47 / 1,485 |
Outcome results
Primary
Incidence of Adverse Events (AEs)
Time frame: Up to 56 weeks
Population: The safety population included all subjects who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALKS 5461 | Incidence of Adverse Events (AEs) | 1124 Participants |