Viewing Study NCT01998958



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Last Modification Date: 2024-10-26 @ 11:15 AM
Study NCT ID: NCT01998958
Status: COMPLETED
Last Update Posted: 2020-06-02
First Post: 2013-11-25

Brief Title: A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression
Sponsor: Janssen Research Development LLC
Organization: Janssen Research Development LLC

Study Overview

Official Title: A Double-Blind Doubly-Randomized Placebo-Controlled Study of Intranasal Esketamine in an Adaptive Treatment Protocol to Assess Safety and Efficacy in Treatment-Resistant Depression SYNAPSE
Status: COMPLETED
Status Verified Date: 2020-05
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: SYNAPSE
Brief Summary: The purpose of this study is to assess the efficacy and dose response of intranasal esketamine Panel A 28 mg 56 mg and 84 mg and Panel B 14 mg and 56 mg compared with placebo in improving depressive symptoms in participants with treatment-resistant depression TRD
Detailed Description: This will be a 2-panel randomized participants are assigned different treatments based on chance double-blind neither investigator nor participant knows which treatment the participant receives placebo-controlled placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial multicenter study Approximately 100 male and female adult participants diagnosed with TRD will participate in this study For participants in both panels Panel A and Panel B there will be 4 study phases a 4-week screening phase a double-blind treatment phase Day 1 to Day 15 an optional open-label treatment phase Panel A Day 15 to 74 Panel B Day 15 to 25 and an 8-week post-treatment follow-up phase Depending on the treatment Panel patients will be assigned to intranasal placebo or intranasal esketamine 14 mg 28 mg 56 mg or 84 mg Safety assessments will be performed throughout the study The maximum study duration for a participant will be 23 weeks for Panel A and 16 weeks for Panel B

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
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?: None
Secondary IDs
Secondary ID Type Domain Link
ESKETINTRD2003 OTHER Janssen Research Development LLC None
2013-004005-11 EUDRACT_NUMBER None None
JNJ-54135419 OTHER None None