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| ID | Type | Description | Link |
|---|---|---|---|
| SPN-820 | Other Identifier | Supernus Pharmaceuticals |
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| Name | Class |
|---|---|
| Supernus Pharmaceuticals, Inc. | INDUSTRY |
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This study will evaluate of the efficacy and safety of SPN-820 in Adults With Major Depressive Disorder (MDD)
This is an open-label study of adjunctive SPN-820 (2400 mg) administered orally once every 3 days in adults with MDD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPN-820 6 x 400 mg capsules | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NV-5138 | Drug | NV-5138 is a novel, orally bioavailable, mechanistic target of rapamycin complex 1 (mTORC1) signaling enhancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). | The HAM-D6 scale consists of 6 items: five of them (depressed mood, work and activities, feeling of guilt, anxiety, psychic, retardation) are scored on a scale of 0 to 4, and one item (somatic symptoms general) is scored on a scale 0 to 2. The total score is the sum of the 6 items ranging from 0 to 22, higher scores indicate severe depression, and lower scores are better outcomes. | 10 days (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. | MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viking Clinical Research | Temecula | California | 92591 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPN-820 (2400 mg) | SPN-820 (2400 mg) oral capsules Participants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The number of participants reported here is based on the Safety Population, which includes participants who took at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | SPN-820 (2400 mg) | SPN-820 (2400 mg) oral capsules Participants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). | The HAM-D6 scale consists of 6 items: five of them (depressed mood, work and activities, feeling of guilt, anxiety, psychic, retardation) are scored on a scale of 0 to 4, and one item (somatic symptoms general) is scored on a scale 0 to 2. The total score is the sum of the 6 items ranging from 0 to 22, higher scores indicate severe depression, and lower scores are better outcomes. | Full Analysis Set (FAS) Population: the FAS includes all participants who receive at least one dose of study medication and have a baseline and at least one post-baseline measurement of HAM-D6. | Posted | Mean | Standard Deviation | score on a scale | 10 days (end of study) |
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Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication up to 12 days (i.e., safety follow up phone call 5 days after the last dose of study medication).
Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPN-820 (2400 mg) | SPN-820 (2400 mg) oral capsules Participants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Development | Navitorpharma | 3018382521 | gceresoliborroni@supernus.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2024 | Sep 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2024 | Aug 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000711091 | NV-5138 |
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Open-label
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| 10 days (end of study) |
| Change From Baseline to Each Time Point in the Clinical Global Impression - Severity of Illness Score (CGI-S). | CGI-S is a single-item clinician rating of the clinician's assessment of the severity of symptoms in relation to the clinician's total experience with patients with that condition. The CGI-I is rated on a 7-point scale from 1 to 7, where 1 = "normal not at all ill" and 7 = "among the most extremely ill patients". Successful therapy is indicated by a lower overall score. | 10 days (end of study) |
| Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported. | 10 days (end of study) |
| Incidence of Treatment Emergent Adverse Events | The incidence of treatment-emergent adverse events (TEAEs) was measured as the percent of participants who took at least one dose of SPN-820 and reported at least one adverse event during 10 days of adjunct treatment. The percent is calculated by dividing "the number of participants who reported at least one Adverse Event" by "the number of participants in the Safety Population" and then multiplying the product by 100. The higher the percent, the higher the incidence. | 10 days (end of study) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| MADRS Total Score | The Montgomery-Åsberg Depression Rating Scale is a diagnostic questionnaire used to measure the severity of depressive episodes. It consists of 10 items (reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts) and each question is scored from 0 to 6 for a total score ranging 0 to 60. Higher scores indicate more severe conditions. | Mean | Standard Deviation | units on a scale |
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| HAM-D6 Total Score | The Hamilton Depression Rating Scale - 6 Items is a diagnostic questionnaire used to measure the severity of depressive episodes. It consists of 6 items (depressed mood, work and activities, somatic symptoms general, feeling of guilt, anxiety psychic, retardation) and each question is scored from 0 to 4 except for one item, somatic symptoms general, which is scored from 0 - 2 for a total score ranging 0 to 22. Higher scores indicate more severe conditions. | Mean | Standard Deviation | units on a scale |
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| CGI-S | The Clinical Global Impression - Severity of Illness is a single-item clinician rating of the clinician's assessment of the severity of symptoms in relation to the clinician's total experience with patients with that condition. CGI-S is evaluated by the Investigator on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. | Mean | Standard Deviation | units on a scale |
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| Secondary | Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. | MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes. | Full Analysis Set (FAS) Population: the FAS includes all participants who receive at least one dose of study medication and have a baseline and at least one post-baseline measurement of HAM-D6. | Posted | Mean | Standard Deviation | score on a scale | 10 days (end of study) |
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| Secondary | Change From Baseline to Each Time Point in the Clinical Global Impression - Severity of Illness Score (CGI-S). | CGI-S is a single-item clinician rating of the clinician's assessment of the severity of symptoms in relation to the clinician's total experience with patients with that condition. The CGI-I is rated on a 7-point scale from 1 to 7, where 1 = "normal not at all ill" and 7 = "among the most extremely ill patients". Successful therapy is indicated by a lower overall score. | Full Analysis Set (FAS) Population: the FAS includes all participants who receive at least one dose of study medication and have a baseline and at least one post-baseline measurement of HAM-D6. | Posted | Mean | Standard Deviation | score on a scale | 10 days (end of study) |
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| Secondary | Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported. | The number of participants reported here is based on the Safety Population, which includes participants who took at least one dose of study medication. | Posted | Number | participants | 10 days (end of study) |
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| Secondary | Incidence of Treatment Emergent Adverse Events | The incidence of treatment-emergent adverse events (TEAEs) was measured as the percent of participants who took at least one dose of SPN-820 and reported at least one adverse event during 10 days of adjunct treatment. The percent is calculated by dividing "the number of participants who reported at least one Adverse Event" by "the number of participants in the Safety Population" and then multiplying the product by 100. The higher the percent, the higher the incidence. | The number of participants reported here is based on the Safety Population, which includes participants who took at least one dose of study medication. | Posted | Number | percentage of participants | 10 days (end of study) |
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| 0 |
| 40 |
| 0 |
| 40 |
| 25 |
| 40 |
| Somnolence | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
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| Cognitive Disorder | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 26.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Day 4 - 4 Hours |
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| Day 7 - Predose |
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| Day 7 - 4 Hours |
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| Day 10 |
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| Day 10 |
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| Day 4 - Suicidal Ideation |
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| Day 4 - Suicidal Behavior |
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| Day 7 - Suicidal Ideation |
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| Day 7 - Suicidal Behavior |
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| Day 10 - Suicidal Ideation |
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| Day 10 - Suicidal Behavior |
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