Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368745
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2006-08-23
Brief Title:
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder GAD Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication Free From Benzodiazepine Use
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study of Pregabalin in Subjects With Generalized Anxiety Disorder GAD Switching From Benzodiazepine Therapy
Status:
COMPLETED
Status Verified Date:
2009-11
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:
GAD
Brief Summary:
GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6 weeks Subjects return weekly for assessment of safetytolerability of pregabalin vs placebo as well as for assessment of anxiety and benzodiazepine withdrawal symptoms Subjects successfully able to discontinue alprazolam will continue 6 weeks of treatment with pregabalin vs placebo free of benzodiazepine use The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to discontinueremain free of alprazolam will be compared among pregabalin and placebo treated groups Hypothesis is that a greater proportion of subjects will be successful in discontinuing and remaining free from benzodiazepines who were treated with pregabalin as compared to subjects treated with placebo
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