NCT03374475

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

An Exploratory, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Subjects With Major Depressive Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	JNJ-42847922 20mg	Participants will swallow 20 mg (2\*10 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
DRUG	JNJ-42847922 40mg	Participants will swallow 40 mg (2\*20 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
DRUG	Placebo	All participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period.

Timeline

• Start date: 2018-01-05
• Primary completion: 2019-04-29
• Completion: 2019-04-29
• First posted: 2017-12-15
• Last updated: 2025-04-27

Locations

14 sites across 5 countries: United States, Belgium, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study