Trial Outcomes & Findings for A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression). (NCT NCT05227209)

NCT ID: NCT05227209

Last Updated: 2025-02-21

Results Overview

Incidence of adverse events

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 64 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-02-21

Participant Flow

The study will consist of a 12-month open-label flexible-dose treatment period, and a safety follow-up period.All subjects will initiate treatment with SEP-4199 CR 200 mg/day. Study medication dose may be increased to 400 mg/day is at the Month 1 visit, based on the Investigator's judgment. The dose may be decreased to a minimum of 200 mg/day at any time thereafter for tolerability.

Participant milestones

Measure	SEP-4199 CR SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily during open-label flexible-dose treatment period.
Overall Study STARTED	64
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	55

Reasons for withdrawal

Measure	SEP-4199 CR SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily during open-label flexible-dose treatment period.
Overall Study Adverse Event	11
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	7
Overall Study Other Early Termination Reason (Not Listed on CRF)	36

Baseline Characteristics

A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).

Baseline characteristics by cohort

Measure	SEP-4199 CR n=64 Participants SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily
Age, Continuous	44.8 Years STANDARD_DEVIATION 12.57 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 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	20 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	1 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Population

Incidence of adverse events

Outcome measures

Measure	SEP-4199 CR n=64 Participants SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily during open-label flexible-dose treatment period.
Number of Subjects Who Experienced Adverse Events in Study	39 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Population

Incidence of adverse events leading to discontinuation

Outcome measures

Measure	SEP-4199 CR n=64 Participants SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily during open-label flexible-dose treatment period.
Number of Subjects Who Discontinued Due to Adverse Events	9 Participants

PRIMARY outcome

Timeframe: 12 months

Incidence of Serious Adverse Events

Outcome measures

Measure	SEP-4199 CR n=64 Participants SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily during open-label flexible-dose treatment period.
Number of Subjects Who Experienced Serious Adverse Events in Study	3 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Safety Population

Open Label (OL) Month 12 (LOCF) is defined as the last non-missing post-OL Baseline measurement up to and including the OL Month 12 measurement and within 9 days post the last dose of open-label extension study medication. The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points and total score range is of 0 to 60 with higher scores indicating increased depressive symptoms.Individual items are then summed to determine total score.

Outcome measures

Measure	SEP-4199 CR n=64 Participants SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily during open-label flexible-dose treatment period.
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Change From Baseline	-6 score on a scale Standard Deviation 12.54

SECONDARY outcome

Timeframe: 12 months

Population: Safety Population

Open Label (OL) Month 12 (LOCF) is defined as the last non-missing post-OL Baseline measurement up to and including the OL Month 12 measurement and within 9 days post the last dose of open-label extension study medication.The Clinical Global Impression Bipolar Version (CGI-BP-S) scale is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity. Depression Score is one the individual item on CGI-BP-S Scale.The CGI-BP-S depression score takes one of the following values: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill patients).

Outcome measures

Measure	SEP-4199 CR n=64 Participants SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily during open-label flexible-dose treatment period.
Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score - Change From Baseline	-0.8 score on a scale Standard Deviation 1.34

Adverse Events

SEP-4199 CR

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	SEP-4199 CR n=64 participants at risk SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily
Immune system disorders Sarcoidosis	1.6% 1/64 • Number of events 1 • 12 months
Psychiatric disorders Psychotic disorder	1.6% 1/64 • Number of events 1 • 12 months
Psychiatric disorders Suicide attempt	1.6% 1/64 • Number of events 1 • 12 months

Other adverse events

Measure	SEP-4199 CR n=64 participants at risk SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily
Infections and infestations Nasopharyngitis	7.8% 5/64 • Number of events 6 • 12 months
Endocrine disorders Hyperprolactinaemia	9.4% 6/64 • Number of events 6 • 12 months
Psychiatric disorders Depression	6.2% 4/64 • Number of events 6 • 12 months
Psychiatric disorders Insomnia	6.2% 4/64 • Number of events 4 • 12 months
Nervous system disorders Headache	6.2% 4/64 • Number of events 4 • 12 months
Investigations Blood prolactin increased	31.2% 20/64 • Number of events 20 • 12 months
Investigations Weight increased	7.8% 5/64 • Number of events 5 • 12 months
Investigations Electrocardiogram QT prolonged	6.2% 4/64 • Number of events 4 • 12 months

Additional Information

CNS Medical Director

Sumitomo Pharma America Inc.

Phone: 1-866-503-6351

Email: clinicaltrialdisclosure@suniovion.com

Results disclosure agreements

• Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
• Publication restrictions are in place

Restriction type: OTHER