drugset / Trial / NCT03374475

A Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Participants With Major Depressive Disorder

NCT03374475

Phase 1 Completed 140 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to explore if the magnitude of treatment effect (JNJ-42847922; placebo) on symptoms of depression (as measured by Hamilton rating scale for depression-17 \[HDRS17\], Sleep item-adjusted HDRS17, Anxiety/somatization factor score and the 6-item subscale from HDRS17 \[HAM-D6\]) differs across different levels of hyper-arousal status (characterized by Sleep parameters, ruminative response scale \[RRS\], Sleep and Worry visual analogue scale \[VAS\], quantitative electro-encephalography \[qEEG\], heart rate variability \[HRV\] and others).

Timeline

Start
2018-01-05
Primary completion
2019-04-29
Completion
2019-04-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Seltorexant Small molecule 20 mg Oral
Subject Seltorexant Small molecule 40 mg Oral