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

Otsuka Pharmaceutical Development & Commercialization, Inc.43 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Schizophrenia Major Depressive Disorder (MDD)Bipolar Disorder

Interventions

SEP-380135DRUG

oral capsule.

PlaceboDRUG

Placebo capsule.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

Outcomes

Primary Outcomes

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

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

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

Time frame: Up to Day 44

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

Time frame: Baseline, Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Baseline, Day 18

All Cohorts: Actual Values of Weight

Time frame: Up to Day 18

All Cohorts: Change From Baseline in Weight

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

All Cohorts: Change From Baseline in BMI

Time frame: Baseline, Day 18

Data from ClinicalTrials.gov

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All Cohorts: Actual Values of Waist Circumference

Time frame: Up to Day 18

All Cohorts: Change From Baseline in Waist Circumference

Time frame: Baseline, Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

All Cohorts: Change From Baseline in QTcF

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

All Cohorts: Change From Baseline in CGI-S Score

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

Cohort 4: Change From Baseline in HAM-A Score

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

Cohort 4: Change From Baseline in MADRS Score

Time frame: Baseline, Day 18

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

Time frame: Up to Day 18

Cohort 4: Change From Baseline in YMRS Score

Time frame: Baseline, Day 18

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

Time frame: Up to Day 17

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

Time frame: Day 14

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

Time frame: Day 14

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

Time frame: Day 14

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

All Cohorts: Cmax of SEP-380135 and its Metabolites

Time frame: Days 1 and 14

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

Time frame: Days 1 and 14

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

Time frame: Days 1 and 14

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

Time frame: Days 1 and 14

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

Time frame: Day 14

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

Time frame: Day 14