drugset
drugset / Trial / NCT07549581

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

NCT07549581 ↗

Phase 1 Completed 43 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
RandomizedSequentialDouble-blindTreatment

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).

Timeline

Start
2024-11-07
Primary completion
2025-09-12
Completion
2025-09-12

Drugs

EvaluationDrugModalityDoseRoute
Subject SEP-380135 Unknown — Oral

Indications

bipolar disorder major depressive disorder schizophrenia