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

NCT03374475 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-04-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-05
Primary Completion
2019-04-29
Completion
2019-04-29
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03374475 on ClinicalTrials.gov