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NCT03227224 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
A Phase 2 study of Depressive Disorder, Major, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 287
- Enrollment target
- 20
- Study locations
NCT03227224: Completed Phase 2 study of Depressive Disorder, Major, sponsored by Janssen Research & Development.
NCT03227224 is a Phase 2 study of Depressive Disorder, Major that has completed, run by Janssen Research & Development. The registered enrollment target is 287 participants, above the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03227224, a Phase 2 study of Depressive Disorder, Major, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 287 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD.
Primary Outcome
MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score
Conditions Studied
Interventions
- DRUG Placebo
- DRUG JNJ-42847922
Study Locations (20)
Florida
- Sarkis Clinical Trials - Gainesville
- Velocity Clinical Research, Hallandale Beach - Hallandale
- Clinical NeuroScience Solutions Inc - Jacksonville
- Innovative Clinical Research Inc - Lauderhill
- Qps-Mra, Llc - Miami
- Galiz Research - Miami Springs
- Behavioral Clinical Research , Inc - North Miami
- Clinical NeuroScience Solutions Inc - Orlando
- Compass Research LLC - Orlando
California
- California Pharmaceutical Research Institute, Inc. - Anaheim
- Catalina Research Institute - Chino
- Synergy Clinical Research Center Of Escondido - Lemon Grove
- Asclepes Research - Panorama City
- Sharp Mesa Vista Hospital - San Diego
- SF-Care, Inc - San Rafael
- Collaborative NeuroScience Network - Torrance
- Elite Clinical Trials - Wildomar
Georgia
- Emory University - Atlanta
- Radiant Research, Inc. - Atlanta
- Atlanta Center for Medical Research - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2017-08-16 |
| Est. Completion | 2019-01-19 |
| Phase | Phase 2 |
What the finished NCT03227224 record still lists
NCT03227224 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, above the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (21% higher).
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03227224 names 20 study sites across 3 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT03227224 about?
NCT03227224 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy". The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants wi...
What is the current status of trial NCT03227224?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 287 participants. The study started on 2017-08-16. Estimated completion is 2019-01-19.
What conditions does trial NCT03227224 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT03227224?
The interventions under investigation include: Placebo (DRUG), JNJ-42847922 (DRUG).
Who is sponsoring clinical trial NCT03227224?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03227224 being conducted?
This trial has 20 study locations across California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Major
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03227224's enrollment target sits among peer trials
287 15th of 52 higher than 38 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major 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.
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