Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232167
Status:
TERMINATED
Last Update Posted:
2007-10-02
First Post:
2005-09-30
Brief Title:
Study Of IndiplonPlacebo With Sertraline In Insomnia Co-Existing With Depression
Sponsor:
Neurocrine Biosciences
Organization:
Neurocrine Biosciences
Study Overview
Official Title:
Multicenter Randomized Double-Blind Placebo-Controlled Study Of The Efficacy And Tolerability Of Indiplon Therapy Initiated With Sertraline Versus Sertraline Monotherapy In Subjects With Insomnia And Co-Existing Major Depressive Disorder
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Please see Detailed Description below for termination reason
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine whether indiplon when administered with sertraline improves insomnia symptoms and depressive symptoms in subjects with both insomnia and depression
Detailed Description:
This Pfizer run study stopped due to the co-development program for indiplon being terminated between Pfizer and Neurocrine The study was terminated on 16 November 2006 There were no safety issues leading to the decision to terminate this study
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