drugset / Trial / NCT05328297

A Study of JNJ-55308942 in the Treatment of Bipolar Depression

NCT05328297 ↗

Phase 2 Completed 116 enrolled Janssen Pharmaceutica N.V., Belgium
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.

Timeline

Start
2022-06-03
Primary completion
2024-05-17
Completion
2024-05-17

Outcome

Missed primary endpoint

registry analysis (superiority test); JNJ-55308942 vs Placebo; p =0.438; Least Square Mean difference -0.3 (80% CI -2.84 to 2.23) NCT05328297 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ZANVIPIXANT Small molecule — Oral

Indications