Carvedilol Versus Placebo for Treatment in Post Traumatic Stress Disorder (PTSD)

Post-Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01221792
• Other study ID #: CVD-PT-10203
• Status: Unknown status
• Phase: Phase 2
• First received: October 14, 2010
• Last updated: June 6, 2011
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: June 2011
• Source: Columbia Northwest Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 80
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Post Traumatic Stress Disorder according to DSM-IV

• Must be able to speak, read and understand the English language and be able to provide written informed consent

Exclusion Criteria:

• current, unstable and significant medical condition/illness

• bronchial asthma or related bronchospastic condition

• AV block

• Sick Sinus Syndrome

• Bradycardia

• Peripheral hear disease

• Unstable thyroid disorder

• History of seizure disorder

• Females who are pregnant, lactating or planning to become pregnant

• Bipolar

• Schizophrenia

• Dementia

• Intolerance or hypersensitivity to alpha or beta blockers

Related Conditions & MeSH terms

• Disease
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Carvedilol
Oral, twice daily dosing using 3.125 mg tablets. 1 week titration (6.25 mg/day)prior to a 3 week flexible dosing option ranging from 6.25 mg/day to 15.625 mg/day followed by a 1 week taper (6.25 mg/day).
• Placebo
Non active comparator

Locations

Country	Name	City	State
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Artemis Institute for Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Columbia Northwest Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Davidson Trauma Scale (DTS)	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 PTSD symptom clusters.; The DTS will be assessed at each study visit (visit 1, 2, 3, 4, 5, 6 and 7). The primary efficacy outcome will be change from baseline (visit 2) to week 5 (visit 7).	5 weeks
Secondary	Clinician Administered PTSD Scale (CAPS)	The CAPS was developed at the National Center for PTSD and has become the "gold standard" for assessing Post Traumatic Stress Disorder. It is a user-friendly structured interview for screening, differential diagnosis, comfirming PTSD diagnosis or identifying Acute Stress Disorder.; The CAPS will be assessed at the screening visit and again at week 5 (vist 7). Change scores (from screening to week 5) will be secondary efficacy measures.	6 Weeks
Secondary	Insomnia Severity Index (ISI)	The ISI is a 7-item patient rated questionnaire that evaluates severity of sleep onset and maintenance difficulties, satisfaction with current sleep pattern interference with daily functioning, appearance of impairment attributed to the sleep problem, and the degree of concern caused by insomnia.; Secondary outcome measures using the ISI will be determined using change scores from baseline to week 5 (visit 7)	5 Weeks

External Links

•   recruitment information and questionnaire