CompletedPhase 1

A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode

United States43 participantsStarted 2024-11-07

Plain-language summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive episode associated with bipolar I or II disorder or major depressive disorder (MDD).

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * BMI from 18.0 to 35.0 kilograms per square meter (kg/m\^2) (inclusive). * Participants with a primary diagnosis of schizophrenia (cohorts 1 to 3) or bipolar I or II disorder or MDD (cohort 4) for at least 1 year (at screening), as established by clinical review, using the DSM-5 as a reference, and confirmed using the Mini international neuropsychiatric interview (MINI). * For cohorts 1 to 3: deemed to have residual symptoms of schizophrenia at screening (i.e., be at least "mildly ill" per CGI-S criteria \[CGI-S greater than or equal to (≥) 3\]) and a PANSS criteria of less than or equal to (≤) 75. For cohort 4 only: deemed to be currently experiencing an MDE. Participants must be at least "moderately ill" per CGI-S criteria (CGI-S ≥ 4). * Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the PI, to comply with all the requirements of the trial. Exclusion Criteria: * Attempted suicide within 12 months prior to screening * A disorder or history of a condition, or previous gastrointestinal conditions that may interfere with drug absorption, distribution, metabolism, excretion, gastrointestinal motility, or pH, or a history of clinically significant abnormality of the hepatic (including participants with moderate \[Child-Pugh Class B\] and severe \[Child-Pugh Class C\] hepatic impairment) or renal system (a glomerular filtration rate less than (\<) 60 milliliters per minute (mL…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All Cohorts: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) Leading to Trial Discontinuation

Timeframe: Up to Day 44

All Cohorts: Percentage of Participants With Suicidal Ideation or Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Up to Day 18

All Cohorts: Percentage of Participants With Withdrawal Symptoms Using the 20-Item Physician Withdrawal Checklist (PWC-20)

Timeframe: Up to Day 44

All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Laboratory Tests

Timeframe: Baseline, Day 18

All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Vital Signs

Timeframe: Baseline, Day 18

All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Orthostatic Effects

Timeframe: Baseline, Day 18

Trial details

NCT IDNCT07549581

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-12

View on ClinicalTrials.gov More Schizophrenia trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

All Cohorts: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) Leading to Trial Discontinuation

Timeframe: Up to Day 44

All Cohorts: Percentage of Participants With Suicidal Ideation or Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Up to Day 18

All Cohorts: Percentage of Participants With Withdrawal Symptoms Using the 20-Item Physician Withdrawal Checklist (PWC-20)

Timeframe: Up to Day 44

All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Laboratory Tests

Timeframe: Baseline, Day 18

All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Vital Signs

Timeframe: Baseline, Day 18

All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Orthostatic Effects

Timeframe: Baseline, Day 18