Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carvedilol | Active Comparator | 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. |
|
| Sugar Pill | Placebo Comparator | Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arifulla Khan, MD | Columbia Northwest Pharmaceuticals, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artemis Institute for Clinical Research | San Diego | California | 92123 | United States | ||
| Lake Charles Clinical Trials |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 1, 2011 | |
| Unrelease | Yes | |
| Release | Sep 23, 2011 | |
| Reset | Oct 31, 2011 | |
| Release | Feb 8, 2012 | |
| Reset | Mar 9, 2012 | |
| Release | Oct 15, 2012 | |
| Reset | Nov 14, 2012 | |
| Release | Aug 14, 2014 | |
| Reset | Aug 27, 2014 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 1, 2011 | Yes | |||
| Sep 23, 2011 |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| D014947 | Wounds and Injuries |
| D020447 | Parasomnias |
| D006987 | Hypesthesia |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Non active comparator |
|
| 6 Weeks |
| 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 |
| Lake Charles |
| Louisiana |
| 70601 |
| United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Oct 31, 2011 |
| Feb 8, 2012 | Mar 9, 2012 |
| Oct 15, 2012 | Nov 14, 2012 |
| Aug 14, 2014 | Aug 27, 2014 |
| D009422 | Nervous System Diseases |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |