Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198094
Status:
COMPLETED
Last Update Posted:
2007-10-22
First Post:
2005-09-12
Brief Title:
A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs SertralinePlacebo for Primary Care Panic Disorder Patients
Status:
COMPLETED
Status Verified Date:
2007-10
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 primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertralineplacebo over a 12-week treatment period The secondary objectives of the study are a to assess withdrawal symptoms during alprazolam XR taper weeks 5-7 of the 12-week trial and after discontinuation b to compare physical health outcomes medical services utilization and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone and c to assess whether early co-administration of sertraline alprazolam XR will result in greater maintenance of treatment response than sertralineplacebo over the three months following the 12 week acute treatment program
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IU 1003 | None | None | None |