Major Depressive Disorder
Conditions
Keywords
Major depressive disorder (MDD), depression, Alkermes, ALKS 5461, samidorphan
Brief summary
This study will evaluate the efficacy and safety of ALKS 5461.
Interventions
DRUGALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
DRUGPlacebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
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
* Have a BMI of 18.0 to 40.0 kg/m2, inclusive * Agree to use an acceptable method of contraception for the duration of the study * Have an MDD primary diagnosis * Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE) * Additional criteria may apply
Exclusion criteria
* 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 one course of electroconvulsive treatment during their lifetime * Have attempted suicide within the past 2 years * Have a positive test for drugs of abuse * Are pregnant, planning to become pregnant, or breastfeeding * 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 60 days * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect | The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms). |
| Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) | The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. |
| Change From Baseline to End of Treatment in the MADRS-10 | 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) | The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) | The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 5). The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. |
| Remission Rate | 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) | The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤10 at the end of the efficacy period. |
| Number of Subjects With Adverse Events (AEs) | 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) | — |
Countries
Canada, Germany, Puerto Rico, 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.
Pre-assignment details
This was a Sequential Parallel Comparison Design (SPCD) study comprised of 2 stages. In Stage 1 subjects were randomized to ALKS 5461 or placebo (2:2:9). In Stage 2 only placebo non-responders from Stage 1 were re-randomized to ALKS 5461 or placebo (1:1:1). 1 subject randomized to the placebo group in Stage 1 did not receive any study drug.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Randomized to placebo in Stage 1 | 280 |
| ALKS 5461 1mg/1mg Randomized to ALKS 5461 1mg/1mg in Stage 1 | 63 |
| ALKS 5461 2mg/2mg Randomized to ALKS 5461 2mg/2mg in Stage 1 | 63 |
| Total | 406 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Stage 1 (S1) | Adverse Event | 6 | 5 | 11 | 0 | 0 | 0 |
| Stage 1 (S1) | Failure to Meet Eligibility Criteria | 1 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 (S1) | Lack of Efficacy | 3 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 (S1) | Lost to Follow-up | 3 | 0 | 1 | 0 | 0 | 0 |
| Stage 1 (S1) | Non-compliance; drug use | 1 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 (S1) | Non-compliance with Study Drug | 2 | 1 | 0 | 0 | 0 | 0 |
| Stage 1 (S1) | Pregnancy | 0 | 0 | 1 | 0 | 0 | 0 |
| Stage 1 (S1) | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 |
| Stage 1 (S1) | Withdrawal by Subject | 6 | 1 | 1 | 0 | 0 | 0 |
| Stage 2 (S2) | Adverse Event | 0 | 0 | 0 | 2 | 3 | 3 |
| Stage 2 (S2) | Failure to Meet Eligibility Criteria | 0 | 0 | 0 | 1 | 0 | 0 |
| Stage 2 (S2) | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 2 |
| Stage 2 (S2) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
| Stage 2 (S2) | Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo | ALKS 5461 1mg/1mg | ALKS 5461 2mg/2mg |
|---|---|---|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 12.93 | 45.7 years STANDARD_DEVIATION 12.87 | 45.1 years STANDARD_DEVIATION 11.46 | 42.9 years STANDARD_DEVIATION 14.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 67 Participants | 48 Participants | 10 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 339 Participants | 232 Participants | 53 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 5 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 95 Participants | 67 Participants | 17 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 301 Participants | 207 Participants | 44 Participants | 50 Participants |
| Region of Enrollment Canada | 7 Participants | 5 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Germany | 64 Participants | 46 Participants | 8 Participants | 10 Participants |
| Region of Enrollment United States | 335 Participants | 229 Participants | 54 Participants | 52 Participants |
| Sex: Female, Male Female | 277 Participants | 193 Participants | 42 Participants | 42 Participants |
| Sex: Female, Male Male | 129 Participants | 87 Participants | 21 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 280 | 0 / 63 | 0 / 63 | 0 / 62 | 0 / 62 | 0 / 63 |
| other Total, other adverse events | 72 / 280 | 25 / 63 | 28 / 63 | 11 / 62 | 6 / 62 | 10 / 63 |
| serious Total, serious adverse events | 1 / 280 | 0 / 63 | 2 / 63 | 1 / 62 | 0 / 62 | 0 / 63 |
Outcome results
Primary
Change From Baseline to End of Treatment in the MADRS-10
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Population: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo S1 | Change From Baseline to End of Treatment in the MADRS-10 | -9.2 Units on a scale | Standard Error 0.55 |
| ALKS 5461 1mg/1mg S1 | Change From Baseline to End of Treatment in the MADRS-10 | -10.3 Units on a scale | Standard Error 1.19 |
| ALKS 5461 2mg/2mg S1 | Change From Baseline to End of Treatment in the MADRS-10 | -10.8 Units on a scale | Standard Error 1.22 |
| Placebo S2 | Change From Baseline to End of Treatment in the MADRS-10 | -1.9 Units on a scale | Standard Error 0.96 |
| ALKS 5461 1mg/1mg S2 | Change From Baseline to End of Treatment in the MADRS-10 | -3.4 Units on a scale | Standard Error 0.98 |
| ALKS 5461 2mg/2mg S2 | Change From Baseline to End of Treatment in the MADRS-10 | -3.6 Units on a scale | Standard Error 0.98 |
Comparison: ALKS 5461 is compared to placebo within each of the 2 stages (i.e., ALKS 5461 2/2 S1 vs Placebo S1; and ALKS 5461 2/2 S2 vs Placebo S2). Efficacy was estimated as a weighted average across 2 stages using equal weights.p-value: 0.07695% CI: [-3.6, 0.2]Mixed Models Analysis
Primary
Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Population: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo S1 | Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -8.1 Units on a scale | Standard Error 0.48 |
| ALKS 5461 1mg/1mg S1 | Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -8.8 Units on a scale | Standard Error 1.05 |
| ALKS 5461 2mg/2mg S1 | Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -10.3 Units on a scale | Standard Error 1.06 |
| Placebo S2 | Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -2.1 Units on a scale | Standard Error 0.88 |
| ALKS 5461 1mg/1mg S2 | Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -3.2 Units on a scale | Standard Error 0.91 |
| ALKS 5461 2mg/2mg S2 | Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -3.7 Units on a scale | Standard Error 0.9 |
Comparison: Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.p-value: 0.02695% CI: [-3.6, -0.2]Mixed Models Analysis
Primary
Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
Time frame: Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect
Population: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS assessment in the respective stage.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo S1 | Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -5.6 Units on a scale | Standard Error 0.34 |
| ALKS 5461 1mg/1mg S1 | Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -6.0 Units on a scale | Standard Error 0.74 |
| ALKS 5461 2mg/2mg S1 | Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -6.8 Units on a scale | Standard Error 0.75 |
| Placebo S2 | Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -1.5 Units on a scale | Standard Error 0.65 |
| ALKS 5461 1mg/1mg S2 | Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -2.2 Units on a scale | Standard Error 0.67 |
| ALKS 5461 2mg/2mg S2 | Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) | -3.2 Units on a scale | Standard Error 0.67 |
Comparison: Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.p-value: 0.01895% CI: [-2.7, -0.3]Mixed Models Analysis
Secondary
Number of Subjects With Adverse Events (AEs)
Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Population: The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo S1 | Number of Subjects With Adverse Events (AEs) | 151 Participants |
| ALKS 5461 1mg/1mg S1 | Number of Subjects With Adverse Events (AEs) | 37 Participants |
| ALKS 5461 2mg/2mg S1 | Number of Subjects With Adverse Events (AEs) | 42 Participants |
| Placebo S2 | Number of Subjects With Adverse Events (AEs) | 25 Participants |
| ALKS 5461 1mg/1mg S2 | Number of Subjects With Adverse Events (AEs) | 29 Participants |
| ALKS 5461 2mg/2mg S2 | Number of Subjects With Adverse Events (AEs) | 25 Participants |
Secondary
Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 5). The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Population: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo S1 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | Yes | 61 Participants |
| Placebo S1 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | No | 212 Participants |
| ALKS 5461 1mg/1mg S1 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | Yes | 17 Participants |
| ALKS 5461 1mg/1mg S1 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | No | 45 Participants |
| ALKS 5461 2mg/2mg S1 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | Yes | 16 Participants |
| ALKS 5461 2mg/2mg S1 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | No | 47 Participants |
| Placebo S2 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | Yes | 7 Participants |
| Placebo S2 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | No | 53 Participants |
| ALKS 5461 1mg/1mg S2 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | Yes | 7 Participants |
| ALKS 5461 1mg/1mg S2 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | No | 55 Participants |
| ALKS 5461 2mg/2mg S2 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | Yes | 6 Participants |
| ALKS 5461 2mg/2mg S2 | Proportion of Patients Who Exhibited Treatment Response (MADRS-10) | No | 57 Participants |
Secondary
Remission Rate
The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤10 at the end of the efficacy period.
Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Population: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 (or HAM-D17) assessment in the respective stage.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo S1 | Remission Rate | No | 242 Participants |
| Placebo S1 | Remission Rate | Yes | 31 Participants |
| ALKS 5461 1mg/1mg S1 | Remission Rate | No | 54 Participants |
| ALKS 5461 1mg/1mg S1 | Remission Rate | Yes | 8 Participants |
| ALKS 5461 2mg/2mg S1 | Remission Rate | No | 55 Participants |
| ALKS 5461 2mg/2mg S1 | Remission Rate | Yes | 8 Participants |
| Placebo S2 | Remission Rate | Yes | 4 Participants |
| Placebo S2 | Remission Rate | No | 56 Participants |
| ALKS 5461 1mg/1mg S2 | Remission Rate | Yes | 6 Participants |
| ALKS 5461 1mg/1mg S2 | Remission Rate | No | 56 Participants |
| ALKS 5461 2mg/2mg S2 | Remission Rate | No | 58 Participants |
| ALKS 5461 2mg/2mg S2 | Remission Rate | Yes | 5 Participants |