Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03188185 | A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD) | PHASE3 | COMPLETED | 278 | — | — | Jun 12, 2017 | Mar 5, 2020 | Apr 8, 2021 | 35 | United States, Australia +1 |
| NCT02218008 | A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study | PHASE3 | COMPLETED | 407 | — | — | Jul 1, 2014 | Oct 1, 2016 | Aug 14, 2019 | 44 | United States, Canada +2 |
| NCT02141399 | A Long-Term Safety Study of ALKS 5461 | PHASE3 | COMPLETED | 1,485 | — | — | May 1, 2014 | Nov 20, 2017 | Dec 14, 2018 | 158 | United States, Australia +6 |
| NCT02158533 | A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study | PHASE3 | COMPLETED | 385 | — | — | May 1, 2014 | Dec 1, 2015 | Aug 14, 2019 | 49 | United States, Australia +1 |
| NCT02158546 | A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study | PHASE3 | COMPLETED | 447 | — | — | May 1, 2014 | Dec 1, 2015 | Jun 25, 2019 | 58 | United States, Bulgaria |
| NCT02085135 | A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD) | PHASE3 | COMPLETED | 66 | — | — | Feb 1, 2014 | Sep 1, 2014 | Aug 14, 2019 | 9 | United States, Canada |
| NCT01500200 | A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD) | PHASE2 | COMPLETED | 142 | — | — | Dec 1, 2011 | Mar 1, 2013 | May 21, 2019 | 27 | United States |
| NCT01381107 | ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD | PHASE1 | COMPLETED | 32 | — | — | May 1, 2011 | Jul 1, 2011 | Aug 23, 2011 | 2 | United States |
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of Major Depressive Disorder (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.
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).
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.
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.
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.
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.
The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.
Measured over a range of dose levels in subjects with inadequate/partial response to antidepressant therapy during the current episode of MDD.
| Arm | Type | Description |
|---|---|---|
| ALKS 5461 | EXPERIMENTAL | Sublingual tablets |
| ALKS 5461 Placebo | PLACEBO_COMPARATOR | Sublingual tablets |
| High Dose | EXPERIMENTAL | - |
| Low Dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Titration Schedule 1 | EXPERIMENTAL | - |
| Titration Schedule 2 | EXPERIMENTAL | - |
| ALKS 5461 (ALKS 33 and buprenorphine) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALKS 5461 | DRUG | Samidorphan + buprenorphine, administered sublingually |
| ALKS 5461 Placebo | DRUG | Placebo tablet, administered sublingually |
| Placebo | DRUG | Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
| High Dose ALKS 5461 | DRUG | Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
| Low Dose ALKS 5461 | DRUG | Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
Inclusion Criteria: * Have a Major Depressive Disorder (MDD) primary diagnosis * Have a body mass index (BMI) of 18.0 to \</= 40.0 kg/m\^2 * Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials) * Ha...