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Also known as High Dose ALKS 5461, Low Dose ALKS 5461
ALKS 5461 · 10 trials · 3 indications
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...
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ALKS 5461 is an investigational small molecule developed by Alkermes plc for major depressive disorder, hepatic impairment, and renal impairment. It has been studied in eight completed clinical trials with a total enrollment of 3,242 participants. The program includes Phase 1 studies in hepatic and renal impairment and Phase 3 studies in treatment refractory major depressive disorder.
ALKS 5461 was studied as a treatment for major depressive disorder, including treatment refractory MDD. Phase 3 trials such as the FORWARD-5 study evaluated ALKS 5461 in adults with MDD. The drug is investigational and has not been approved for any indication.
ALKS 5461 is being developed by Alkermes plc, which trades on the Nasdaq under the ticker ALKS. Alkermes sponsored the clinical trials of ALKS 5461, including Phase 1 studies in hepatic and renal impairment and Phase 3 studies in major depressive disorder.
ALKS 5461 has completed Phase 1 and Phase 3 clinical trials. The Phase 1 program evaluated pharmacokinetics and safety in hepatic and renal impairment, while Phase 3 trials studied major depressive disorder. There are currently no active trials of ALKS 5461, and the drug remains investigational.
ALKS 5461 has been evaluated in eight completed clinical trials, including NCT03188185, a Phase 3 study in treatment refractory major depressive disorder; NCT02218008, the Phase 3 FORWARD-5 study in MDD; NCT02508506, a Phase 1 renal impairment study; and NCT02452801, a Phase 1 hepatic impairment study. All trials are completed.
Yes, High Dose ALKS 5461 is an alternative name for ALKS 5461. Both refer to the same investigational small molecule developed by Alkermes plc for major depressive disorder, hepatic impairment, and renal impairment.