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NCT03374475 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
140
Enrollment target

NCT03374475: Completed Phase 1 study, sponsored by Janssen Research & Development.

NCT03374475 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 140 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03374475, a Phase 1 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
140 participants
Enrollment target

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).

Primary Outcome

The HDRS17 is a Clinician-Administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a total score range of 0 to 52. It is the most widely used symptom severity measure for depression. Each of the 17 items is rated by the clinician on either a 3- point (0 to 2) or a 5-point scale (0 to 4). The point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Total score will

Interventions

  • DRUG Placebo
  • DRUG JNJ-42847922 20mg
  • DRUG JNJ-42847922 40mg

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2018-01-05
Est. Completion 2019-04-29
Phase Phase 1
Janssen Research & Development

593 total trials

What the finished NCT03374475 record still lists

NCT03374475 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03374475 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03374475 about?

NCT03374475 is a clinical study titled "A Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Participants With Major Depressive Disorder". 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-D...

What is the current status of trial NCT03374475?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2018-01-05. Estimated completion is 2019-04-29.

What interventions are being tested in trial NCT03374475?

The interventions under investigation include: Placebo (DRUG), JNJ-42847922 20mg (DRUG), JNJ-42847922 40mg (DRUG).

Who is sponsoring clinical trial NCT03374475?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03374475's enrollment target sits among peer trials

140 402nd of 2000 higher than 1,583 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03374475, the US trial registry maintained by the National Library of Medicine. NCT03374475 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.