Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT02476058
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2015-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety, Efficacy and Biomarker Study of JNJ-42847922 in Participants With Major Depressive Disorder
Sponsor:
Janssen-Cilag International NV
Organization:
Study Overview
Official Title:
An Exploratory Multicenter, Double-Blind, Diphenhydramine- and Placebo-Controlled Safety, Efficacy and Biomarker Study With JNJ-42847922 in Subjects With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of JNJ-42847922 in participants with Major Depressive Disorder (MDD).
Detailed Description:
This will be a multi-center (when more than one hospital works on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving) and placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. This study will consist of an eligibility screening examination (between 28 days and 1 day prior to the first dose administration), a parallel group treatment phase of 10 days or 4 weeks, and a follow-up period of 2 weeks including 2 follow-up visits. The duration of study will be 12 months. Participants will be randomly assigned to receive either JNJ-42847922, Diphenhydramine or Placebo. Participants' safety will be monitored throughout the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: