Refractory Major Depressive Disorder
Conditions
Keywords
Alkermes, Major depressive disorder, Depression, ALKS 5461
Brief summary
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.
Interventions
DRUGALKS 5461
samidorphan + buprenorphine administered sublingually
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Completed study ALK5461-217 * Be willing to abide by the contraception requirements as outlined in the study protocol * Be willing and able to follow the study procedures and visits as outlined in the protocol * Additional criteria may apply
Exclusion criteria
* Pregnant, planning to become pregnant, or breastfeeding * A positive urine drug test for drugs of abuse * Poses a current suicide risk * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Up to 68 weeks | Number and percentage of subjects experiencing TEAEs |
Countries
Australia, Puerto Rico, United States
Participant flow
Recruitment details
Subjects that had completed the 12-week treatment period in the antecedent study ALK5461-217 were eligible to be enrolled in the study.
Pre-assignment details
A total of 175 patients were administered at least one dose of ALKS 5461 and included in the safety population.
Participants by arm
| Arm | Count |
|---|---|
| ALKS 5461 All subjects assigned to ALKS 5461
Sublingual tablets
ALKS 5461: samidorphan + buprenorphine administered sublingually | 175 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 32 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Other | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Study terminated by sponsor | 84 |
| Overall Study | Withdrawal by Subject | 31 |
Baseline characteristics
| Characteristic | ALKS 5461 |
|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 12.87 |
| Age, Customized <55 years | 127 Participants |
| Age, Customized >=55 years | 48 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 151 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 148 Participants |
| Region of Enrollment Australia | 23 participants |
| Region of Enrollment Puerto Rico | 10 participants |
| Region of Enrollment United States | 142 participants |
| Sex: Female, Male Female | 122 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 175 |
| other Total, other adverse events | 85 / 175 |
| serious Total, serious adverse events | 4 / 175 |
Outcome results
Primary
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Number and percentage of subjects experiencing TEAEs
Time frame: Up to 68 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALKS 5461 | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | 108 Participants |