drugset / Trial / NCT02395978

A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder

NCT02395978 ↗

Phase 2 Completed 72 enrolled BioLite, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy in patients with major depressive disorder.

Timeline

Start
2015-04-10
Primary completion
2019-03-12
Completion
2019-03-18

Outcome

Missed primary endpoint

registry analysis (superiority test); Part II: 2 PDC-1421 Capsule vs Part II: 1 PDC-1421 Capsule Plus 1 Placebo vs Part II: 2 Placebo; p = 0.393; Kruskal-Wallis NCT02395978 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject PDC-1421 Unknown 1 unknown Oral
Subject PDC-1421 Unknown 2 unknown Oral