Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-25 @ 3:33 PM
Study NCT ID:
NCT01221792
Status:
UNKNOWN
Last Update Posted:
2011-06-08
First Post:
2010-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carvedilol Versus Placebo for Treatment in Post Traumatic Stress Disorder (PTSD)
Sponsor:
Columbia Northwest Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety and Efficacy of Carvedilol Versus Placebo in the Treatment of Post Traumatic Stress Disorder
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.
Detailed Description:
This initial proof of concept trial design is intended to explore multiple variables. Fist, it is intended to determine if carvedilol has any statistically significant effect over placebo on the various overall symptoms, symptom clusters, or individual symptoms of post traumatic stress disorder. Next, the flexible dosing trial design is aimed to detect the therapeutic dose, or dosing range for carvedilol when used in the treatment of PTSD
Study Oversight
Has Oversight DMC:
False
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?: