Trial Outcomes & Findings for Open-Label of SPN-820 in Adults With Major Depressive Disorder (NCT NCT06235905)

NCT ID: NCT06235905

Last Updated: 2025-10-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: 10 days (end of study)
• Results posted on: 2025-10-21

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	40
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	1
Overall Study Non-compliant with protocol procedures	1

Baseline Characteristics

Open-Label of SPN-820 in Adults With Major Depressive Disorder

Baseline characteristics by cohort

Measure	SPN-820 (2400 mg) n=40 Participants 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.
Age, Continuous	44.7 years STANDARD_DEVIATION 15.39 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants
MADRS Total Score	33.1 units on a scale STANDARD_DEVIATION 5.41 • n=5 Participants
HAM-D6 Total Score	13.6 units on a scale STANDARD_DEVIATION 1.69 • n=5 Participants
CGI-S	4.6 units on a scale STANDARD_DEVIATION 0.64 • n=5 Participants

PRIMARY outcome

Timeframe: 10 days (end of study)

Population: 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.

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.

Outcome measures

Measure	SPN-820 (2400 mg) n=40 Participants 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.
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 1 - 2 Hours	-6.1 score on a scale Standard Deviation 3.90
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 1 - 4 Hours	-7.2 score on a scale Standard Deviation 3.96
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 1 - 8 Hours	-7.5 score on a scale Standard Deviation 3.59
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 2	-7.8 score on a scale Standard Deviation 3.58
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 3	-8.7 score on a scale Standard Deviation 3.47
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 4 - Predose	-7.2 score on a scale Standard Deviation 3.04
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 4 - 2 Hours	-8.9 score on a scale Standard Deviation 3.45
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 4 - 4 Hours	-9.5 score on a scale Standard Deviation 3.33
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 4 - 8 Hours	-9.7 score on a scale Standard Deviation 3.33
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 5	-9.3 score on a scale Standard Deviation 3.37
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 6	-9.8 score on a scale Standard Deviation 3.22
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 7 - Predose	-9.2 score on a scale Standard Deviation 3.38
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 7 - 2 Hours	-9.9 score on a scale Standard Deviation 3.09
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 7 - 4 Hours	-9.7 score on a scale Standard Deviation 3.11
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 7 - 8 Hours	-10.2 score on a scale Standard Deviation 3.21
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 8	-9.8 score on a scale Standard Deviation 3.15
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 9	-9.9 score on a scale Standard Deviation 2.67
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6). Day 10	-9.6 score on a scale Standard Deviation 3.18

SECONDARY outcome

Timeframe: 10 days (end of study)

Population: 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.

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.

Outcome measures

Measure	SPN-820 (2400 mg) n=40 Participants 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.
Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. Day 1 - 4 Hours	-16.6 score on a scale Standard Deviation 10.06
Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. Day 4 - Predose	-16.6 score on a scale Standard Deviation 9.05
Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. Day 4 - 4 Hours	-21.2 score on a scale Standard Deviation 9.93
Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. Day 7 - Predose	-21.2 score on a scale Standard Deviation 9.83
Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. Day 7 - 4 Hours	-23.3 score on a scale Standard Deviation 10.60
Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. Day 10	-22.9 score on a scale Standard Deviation 9.98

SECONDARY outcome

Timeframe: 10 days (end of study)

Population: 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.

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.

Outcome measures

Measure	SPN-820 (2400 mg) n=40 Participants 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.
Change From Baseline to Each Time Point in the Clinical Global Impression - Severity of Illness Score (CGI-S). Day 4	-1.5 score on a scale Standard Deviation 1.08
Change From Baseline to Each Time Point in the Clinical Global Impression - Severity of Illness Score (CGI-S). Day 7	-2.2 score on a scale Standard Deviation 1.21
Change From Baseline to Each Time Point in the Clinical Global Impression - Severity of Illness Score (CGI-S). Day 10	-2.4 score on a scale Standard Deviation 1.35

SECONDARY outcome

Timeframe: 10 days (end of study)

Population: The number of participants reported here is based on the Safety Population, which includes participants who took at least one dose of study medication.

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.

Outcome measures

Measure	SPN-820 (2400 mg) n=40 Participants 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.
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Day 1 (Baseline) - Suicidal Ideation	5 participants
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Day 1 (Baseline) - Behavior	0 participants
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Day 4 - Suicidal Ideation	2 participants
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Day 4 - Suicidal Behavior	0 participants
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Day 7 - Suicidal Ideation	2 participants
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Day 7 - Suicidal Behavior	0 participants
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Day 10 - Suicidal Ideation	1 participants
Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Day 10 - Suicidal Behavior	0 participants

SECONDARY outcome

Timeframe: 10 days (end of study)

Population: The number of participants reported here is based on the Safety Population, which includes participants who took at least one dose of study medication.

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.

Outcome measures

Measure	SPN-820 (2400 mg) n=40 Participants 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.
Incidence of Treatment Emergent Adverse Events	62.5 percentage of participants

Adverse Events

SPN-820 (2400 mg)

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SPN-820 (2400 mg) n=40 participants at risk 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.
Nervous system disorders Headache	20.0% 8/40 • Number of events 8 • 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.
Nervous system disorders Somnolence	15.0% 6/40 • Number of events 8 • 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.
Nervous system disorders Dizziness	10.0% 4/40 • Number of events 6 • 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.
Nervous system disorders Cognitive Disorder	5.0% 2/40 • Number of events 2 • 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.
Gastrointestinal disorders Nausea	20.0% 8/40 • Number of events 9 • 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.
Gastrointestinal disorders Dry mouth	5.0% 2/40 • Number of events 3 • 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.
Gastrointestinal disorders Paraesthesia oral	5.0% 2/40 • Number of events 3 • 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.
General disorders Fatigue	5.0% 2/40 • Number of events 5 • 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.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.0% 2/40 • Number of events 4 • 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.

Additional Information

Senior Director Clinical Development

Navitorpharma

Phone: 3018382521

Email: gceresoliborroni@supernus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place