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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants receive SEP-380135 Dose Level 1, orally once daily (QD) from Day 1 to Day 14. |
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| Cohort 2 | Experimental | Participants receive SEP-380135 Dose Level 2 orally once daily (QD) from Day 1 through Day 14. |
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| Cohort 3 | Experimental | Participants receive SEP-380135 Dose Level 3 orally once daily (QD) from Day 1 through Day 14. |
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| Cohort 4 | Experimental | Participants receive SEP-380135 Dose Level 4 orally once daily (QD) from Day 1 through Day 14. |
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| Placebo | Placebo Comparator | Participants receive SEP-380135 matching-placebo orally orally once daily (QD) from Day 1 to Day 14. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEP-380135 | Drug | oral capsule. |
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| Measure | Description | Time Frame |
|---|---|---|
| All Cohorts: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) Leading to Trial Discontinuation | Up to Day 44 | |
| All Cohorts: Percentage of Participants With Suicidal Ideation or Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 18 | |
| All Cohorts: Percentage of Participants With Withdrawal Symptoms Using the 20-Item Physician Withdrawal Checklist (PWC-20) | Up to Day 44 | |
| All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Laboratory Tests | Baseline, Day 18 | |
| All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Vital Signs | Baseline, Day 18 | |
| All Cohorts: Percentage of Participants With Change From Baseline in Potentially Clinically Relevant Orthostatic Effects | Baseline, Day 18 | |
| All Cohorts: Actual Values of Weight | Up to Day 18 | |
| All Cohorts: Change From Baseline in Weight | Baseline, Day 18 | |
| All Cohorts: Actual Values of Body Mass Index (BMI) | Up to Day 18 | |
| Measure | Description | Time Frame |
|---|---|---|
| All Cohorts: Cmax of SEP-380135 and its Metabolites | Days 1 and 14 | |
| All Cohorts: Time to Maximum Plasma Concentration (tmax) of SEP-380135 and its Metabolites | Days 1 and 14 | |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Research, LLC | Los Alamitos | California | 90720 | United States |
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| Label | URL |
|---|---|
| Otsuka Clinical Trials website | View source |
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Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| Placebo | Drug | Placebo capsule. |
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| All Cohorts: Change From Baseline in BMI |
| Baseline, Day 18 |
| All Cohorts: Actual Values of Waist Circumference | Up to Day 18 |
| All Cohorts: Change From Baseline in Waist Circumference | Baseline, Day 18 |
| All Cohorts: Percentage of Participants With Change From Baseline in 12-Lead Electrocardiogram (ECG) | Baseline, Day 18 |
| All Cohorts: Actual Values of QT interval corrected using Fridericia's Formula (QTcF) | Up to Day 18 |
| All Cohorts: Change From Baseline in QTcF | Baseline, Day 18 |
| Cohorts 1, 2, and 3: Actual Values of Clinician-Administered Dissociative States Scale (CADSS) Score | Up to Day 18 |
| Cohorts 1, 2, and 3: Change From Baseline in CADSS Score | Baseline, Day 18 |
| All Cohorts: Actual Values of Drug Effect Questionnaire (DEQ) Scored Using Visual Analog Scale Score | Up to Day 18 |
| All Cohorts: Change From Baseline in DEQ Scored Using Visual Analog Scale Score | Baseline, Day 18 |
| Cohorts 1, 2, and 3: Actual Values of Barnes Akathisia Rating Scale (BARS) Score | Up to Day 18 |
| Cohorts 1, 2, and 3: Change From Baseline in BARS Score | Baseline, Day 18 |
| Cohorts 1, 2, and 3: Actual Values of Abnormal Involuntary Movement Scale (AIMS) Score | Up to Day 18 |
| Cohorts 1, 2, and 3: Change From Baseline in AIMS Score | Baseline, Day 18 |
| Cohorts 1, 2, and 3: Actual Values of Simpson Angus Scale (SAS) Score | Up to Day 18 |
| Cohorts 1, 2, and 3: Change From Baseline in SAS Score | Baseline, Day 18 |
| Cohorts 1, 2, and 3: Actual Values of Positive and Negative Syndrome Scale (PANSS) Score | Up to Day 18 |
| Cohorts 1, 2, and 3: Change From Baseline in PANSS Score | Baseline, Day 18 |
| All Cohorts: Actual Values of Clinical Global Impressions-Severity Scale (CGI-S) Score | Up to Day 18 |
| All Cohorts: Change From Baseline in CGI-S Score | Baseline, Day 18 |
| Cohorts 1, 2, and 3: Actual Values of Calgary Depression Scale for Schizophrenia (CDSS) Score | Up to Day 18 |
| Cohorts 1, 2, and 3: Change From Baseline in CDSS Score | Baseline, Day 18 |
| All Cohorts: Percentage of Participants With Change From Baseline in Physical Examinations | Baseline, Day 18 |
| All Cohorts: Percentage of Participants With Change From Baseline in Neurological Examinations | Baseline, Day 18 |
| Cohort 4: Actual Values of Hamilton Anxiety Rating Scale (HAM-A) Score | Up to Day 18 |
| Cohort 4: Change From Baseline in HAM-A Score | Baseline, Day 18 |
| Cohort 4: Actual Values of Montgomery-Asberg Depression Rating Scale (MADRS) Score | Up to Day 18 |
| Cohort 4: Change From Baseline in MADRS Score | Baseline, Day 18 |
| Cohort 4: Actual Values of Young Mania Rating Scale (YMRS) Score | Up to Day 18 |
| Cohort 4: Change From Baseline in YMRS Score | Baseline, Day 18 |
| All Cohorts: Percentage of Participants With Changes in Quantitative Sleep Parameters Measured Using Electroencephalography (EEG) | Up to Day 17 |
| All Cohorts: Apparent Clearance (CL/F) of SEP-380135 | Day 14 |
| All Cohorts: Volume of Distribution (Vz/F) of SEP-380135 | Day 14 |
| All Cohorts: Maximum Plasma Concentration (Cmax) of SEP-380135 | Day 14 |
| All Cohorts: Area Under the Drug Concentration-time Curve From Time Zero Predose to 24 hours Postdose (AUC0-24h) of SEP-380135 | Day 14 |
| All Cohorts: AUC0-24h of SEP-380135 and its Metabolites |
| Days 1 and 14 |
| All Cohorts: Observed Plasma Concentration at 24 hours Postdose (C24h) of SEP-380135 | Days 1 and 14 |
| All Cohorts: Terminal Phase Elimination Half-Life (t1/2,z) of SEP-380135 and its Metabolites | Day 14 |
| All Cohorts: Serum Concentration of SEP-380135 at Steady-State | Day 14 |
| D000068105 | Bipolar and Related Disorders |