New drug SEP-380135 tested for safety in schizophrenia and depression
NCT ID NCT07549581
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new oral drug, SEP-380135, in 43 adults with schizophrenia or major depression (including bipolar disorder). The main goal was to check its safety and how the body processes it. Participants took multiple doses and were monitored for side effects, vital signs, and mood changes. This trial did not aim to treat the conditions but to gather essential safety data for future research.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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43 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720, United States
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