NCT01221792

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 Phase 2 Last updated 6 June 2011

What this trial tests

Phase 2 trial testing Carvedilol in Post-Traumatic Stress Disorder in 80 participants. Status unknown.

Timeline

1 October 2010

Primary endpoint
1 June 2011

1 August 2011

Quick facts

Lead sponsor	Columbia Northwest Pharmaceuticals
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	1 October 2010
Primary completion	1 June 2011
Estimated completion	1 August 2011
Sites	3 locations across United States

Drugs / interventions tested

• Carvedilol (CARVEDILOL) — full drug profile →
• Placebo

Conditions studied

• Post-Traumatic Stress Disorder — all drugs for Post-Traumatic Stress Disorder →

Sponsor

Columbia Northwest Pharmaceuticals

Who can join

Adults 18 to 70, any sex, with Post-Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Davidson Trauma Scale (DTS)
  Time frame: 5 weeks
  The DTS is a 17-item self report measure to assess the 17 DMS-IV symptoms of PTSD. Respondants are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they hav had with each symptom. The DTS can be used to make a preliminatry determination about whether the symptoms meet DSM criteria for PTSD, or scores can be calculated for each of the 3 PT

Sponsor's own description

The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacotherapy for post traumatic stress disorder (PTSD).
   Williams T, Phillips NJ, Stein DJ, Ipser JC. · · 2022 · cited 62× · PMID 35234292 · DOI 10.1002/14651858.cd002795.pub3