Ignite Creation Date:
2024-05-06 @ 4:25 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04971291
Status:
UNKNOWN
Last Update Posted:
2021-07-26
First Post:
2021-07-12
Brief Title:
An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients
Sponsor:
Axsome Therapeutics Inc
Organization:
Axsome Therapeutics Inc
Study Overview
Official Title:
A Randomized Active-Controlled Evaluation of AXS-05 for the Treatment of Treatment Resistant Depression in Treatment-Adherent Patients
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
ENROLLING_BY_INVITATION
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:
TARGET
Brief Summary:
The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder MDD who are adherent to study drug Subjects are considered to have treatment-resistant MDD if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments ADTs and a prospective inadequate response to treatment with bupropion SR during the current major depressive episode
The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan in the AXS-05 group and bupropion in the bupropion group and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301
The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan in the AXS-05 group and bupropion in the bupropion group and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None