At a glance
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A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of JNJ-67953964 in Subjects With Major Depressive Disorder
In Brief
A Phase 2 clinical trial evaluating JNJ-67953964 and Placebo for Depressive Disorder, Major. Completed, enrolled 181 participants across 53 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment in terms of reduction of symptoms of depression, as assessed by the change from baseline on the Montgomery Asberg Depression Rating Scale (MADRS) in non-responders during the placebo lead-in period.
Study Details
Timeline
Interventions
JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily.
Matching placebo will be administered as 2 capsules orally once daily.