Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01381107
Status:
COMPLETED
Last Update Posted:
2011-08-23
First Post:
2011-06-16
Brief Title:
ALK33BUP-201 Safety and Tolerability Study of ALKS 33-BUP ALKS 5461 Administration in Subjects With MDD
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Study Evaluating Safety and Tolerability of ALKS 33-BUP Administration in Subjects With Major Depressive Disorder MDD
Status:
COMPLETED
Status Verified Date:
2011-08
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:
This is a multicenter randomized double-blind placebo-controlled parallel multiple dose study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with buprenorphine ALKS 5461 in subjects with Major Depressive Disorder MDD who are inadequatelypartially responding to current treatment with a stable dose of a serotonin-selective reuptake inhibitor SSRI or serotonin-norepinephrine reuptake inhibitor SNRI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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