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Completed

NCT Number: NCT07549581

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

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).

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depressive Disorder (MDD) Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Research, LLC

Los Alamitos, California, 90720, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/min)), or a history of malabsorption, bowel resection, bariatric surgery or gastric band/lap band surgery, or is on medications that might interfere with gastric motility.
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin ≥ 2 times the upper limit of the reference ranges provided by the safety laboratory at screening, or total bilirubin ≥ 2 times the upper limit of reference (except for participants with Gilbert's syndrome or similar condition).
  • Has any clinically significant unstable medical condition, clinically significant chronic disease, or any psychiatric symptom or diagnosis that in the opinion of the investigator, MM, or sponsor would pose a risk to the participant or the scientific objectives of the trial.

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Treatment and study plan

SEP-380135

Drug

oral capsule.

Placebo

Drug

Placebo capsule.

Primary outcomes

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

    Time frame: Up to Day 44

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

    Time frame: Up to Day 18

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

    Time frame: Up to Day 44

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

    Time frame: Baseline, Day 18

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

    Time frame: Baseline, Day 18

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

    Time frame: Baseline, Day 18

  7. All Cohorts: Actual Values of Weight

    Time frame: Up to Day 18

  8. All Cohorts: Change From Baseline in Weight

    Time frame: Baseline, Day 18

  9. All Cohorts: Actual Values of Body Mass Index (BMI)

    Time frame: Up to Day 18

  10. All Cohorts: Change From Baseline in BMI

    Time frame: Baseline, Day 18

  11. All Cohorts: Actual Values of Waist Circumference

    Time frame: Up to Day 18

  12. All Cohorts: Change From Baseline in Waist Circumference

    Time frame: Baseline, Day 18

  13. All Cohorts: Percentage of Participants With Change From Baseline in 12-Lead Electrocardiogram (ECG)

    Time frame: Baseline, Day 18

  14. All Cohorts: Actual Values of QT interval corrected using Fridericia's Formula (QTcF)

    Time frame: Up to Day 18

  15. All Cohorts: Change From Baseline in QTcF

    Time frame: Baseline, Day 18

  16. Cohorts 1, 2, and 3: Actual Values of Clinician-Administered Dissociative States Scale (CADSS) Score

    Time frame: Up to Day 18

  17. Cohorts 1, 2, and 3: Change From Baseline in CADSS Score

    Time frame: Baseline, Day 18

  18. All Cohorts: Actual Values of Drug Effect Questionnaire (DEQ) Scored Using Visual Analog Scale Score

    Time frame: Up to Day 18

  19. All Cohorts: Change From Baseline in DEQ Scored Using Visual Analog Scale Score

    Time frame: Baseline, Day 18

  20. Cohorts 1, 2, and 3: Actual Values of Barnes Akathisia Rating Scale (BARS) Score

    Time frame: Up to Day 18

  21. Cohorts 1, 2, and 3: Change From Baseline in BARS Score

    Time frame: Baseline, Day 18

  22. Cohorts 1, 2, and 3: Actual Values of Abnormal Involuntary Movement Scale (AIMS) Score

    Time frame: Up to Day 18

  23. Cohorts 1, 2, and 3: Change From Baseline in AIMS Score

    Time frame: Baseline, Day 18

  24. Cohorts 1, 2, and 3: Actual Values of Simpson Angus Scale (SAS) Score

    Time frame: Up to Day 18

  25. Cohorts 1, 2, and 3: Change From Baseline in SAS Score

    Time frame: Baseline, Day 18

  26. Cohorts 1, 2, and 3: Actual Values of Positive and Negative Syndrome Scale (PANSS) Score

    Time frame: Up to Day 18

  27. Cohorts 1, 2, and 3: Change From Baseline in PANSS Score

    Time frame: Baseline, Day 18

  28. All Cohorts: Actual Values of Clinical Global Impressions-Severity Scale (CGI-S) Score

    Time frame: Up to Day 18

  29. All Cohorts: Change From Baseline in CGI-S Score

    Time frame: Baseline, Day 18

  30. Cohorts 1, 2, and 3: Actual Values of Calgary Depression Scale for Schizophrenia (CDSS) Score

    Time frame: Up to Day 18

  31. Cohorts 1, 2, and 3: Change From Baseline in CDSS Score

    Time frame: Baseline, Day 18

  32. All Cohorts: Percentage of Participants With Change From Baseline in Physical Examinations

    Time frame: Baseline, Day 18

  33. All Cohorts: Percentage of Participants With Change From Baseline in Neurological Examinations

    Time frame: Baseline, Day 18

  34. Cohort 4: Actual Values of Hamilton Anxiety Rating Scale (HAM-A) Score

    Time frame: Up to Day 18

  35. Cohort 4: Change From Baseline in HAM-A Score

    Time frame: Baseline, Day 18

  36. Cohort 4: Actual Values of Montgomery-Asberg Depression Rating Scale (MADRS) Score

    Time frame: Up to Day 18

  37. Cohort 4: Change From Baseline in MADRS Score

    Time frame: Baseline, Day 18

  38. Cohort 4: Actual Values of Young Mania Rating Scale (YMRS) Score

    Time frame: Up to Day 18

  39. Cohort 4: Change From Baseline in YMRS Score

    Time frame: Baseline, Day 18

  40. All Cohorts: Percentage of Participants With Changes in Quantitative Sleep Parameters Measured Using Electroencephalography (EEG)

    Time frame: Up to Day 17

  41. All Cohorts: Apparent Clearance (CL/F) of SEP-380135

    Time frame: Day 14

  42. All Cohorts: Volume of Distribution (Vz/F) of SEP-380135

    Time frame: Day 14

  43. All Cohorts: Maximum Plasma Concentration (Cmax) of SEP-380135

    Time frame: Day 14

  44. All Cohorts: Area Under the Drug Concentration-time Curve From Time Zero Predose to 24 hours Postdose (AUC0-24h) of SEP-380135

    Time frame: Day 14

Secondary outcomes

  1. All Cohorts: Cmax of SEP-380135 and its Metabolites

    Time frame: Days 1 and 14

  2. All Cohorts: Time to Maximum Plasma Concentration (tmax) of SEP-380135 and its Metabolites

    Time frame: Days 1 and 14

  3. All Cohorts: AUC0-24h of SEP-380135 and its Metabolites

    Time frame: Days 1 and 14

  4. All Cohorts: Observed Plasma Concentration at 24 hours Postdose (C24h) of SEP-380135

    Time frame: Days 1 and 14

  5. All Cohorts: Terminal Phase Elimination Half-Life (t1/2,z) of SEP-380135 and its Metabolites

    Time frame: Day 14

  6. All Cohorts: Serum Concentration of SEP-380135 at Steady-State

    Time frame: Day 14

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Phase 1b, Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of SEP-380135 in Adults With Schizophrenia or With a Major Depressive Episode Associated With Bipolar I or II Disorder or Major Depressive Disorder

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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