Carvedilol Versus Placebo for Treatment in Post Traumatic Stress Disorder (PTSD)
Recruitment status was Active, not recruiting
The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Davidson Trauma Scale (DTS) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
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).
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
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.
- Insomnia Severity Index (ISI) [ Time Frame: 5 Weeks ] [ Designated as safety issue: No ]
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)
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||August 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Active Comparator: carvedilol
Patients randomized to carvedilol will be administered doses ranging from 6.25 to 15.625 mg/day using a flexible-dosing model. After a 1 week titration, investigators my increase daily dose by 6.25 mg/day at weeks 1 and 2 for a maximum dose of 15.625 mg/day. Weeks 3-4 will patients will remain on a stable, tolerable dose. At week 5 patients will have a 1 week taper.
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).
Other Name: Coreg(R)
Placebo Comparator: Sugar Pill
Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol.
Non active comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221792
|United States, California|
|Artemis Institute for Clinical Research|
|San Diego, California, United States, 92123|
|United States, Louisiana|
|Lake Charles Clinical Trials|
|Lake Charles, Louisiana, United States, 70601|
|United States, Washington|
|Northwest Clinical Research Center|
|Bellevue, Washington, United States, 98007|
|Study Director:||Arifulla Khan, MD||Columbia Northwest Pharmaceuticals, LLC|