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Clinical trial

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

NCT07549581 is registered in ClinicalTrials.gov with Otsuka Pharmaceutical Development & Commercialization, Inc. as lead sponsor.

NCT NCT07549581
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase
Phase 1
Overall status
Completed
Start date
November 7, 2024
Completion date
September 12, 2025
Enrollment
43 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bipolar disorder, major depressive disorder (mdd), schizophrenia