Post-Traumatic Stress Disorder
Conditions
Keywords
PTSD, Anxiety, Trauma, Assault, Victim, Witness, Post Traumatic Stress Disorder, Combat veteran, Flashbacks, Nightmares, Sleep Disturbance, Hyperarousal, Numbness, Avoidance
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
Interventions
DRUGCarvedilol
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).
DRUGPlacebo
Non active comparator
Sponsors
Columbia Northwest Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Davidson Trauma Scale (DTS) | 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 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) | 6 Weeks | 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) | 5 Weeks | 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) |
Countries
United States
Outcome results
None listed