clinical trial · NCT07549581
A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode
Otsuka Pharmaceutical Development & Commercialization, Inc.·phase1·completed·n = 43
SchizophreniaMajor Depressive Disorder (MDD)Bipolar DisorderSEP-380135Placebo
brief 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).
started
Nov 7, 2024
primary completion
Sep 12, 2025
completion
Sep 12, 2025
last updated
Apr 24, 2026
official 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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol