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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Columbia Northwest Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01221792
First received: October 14, 2010
Last updated: June 6, 2011
Last verified: June 2011
History of Changes

October 14, 2010
June 6, 2011
October 2010
June 2011   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01221792 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Carvedilol Versus Placebo for Treatment in Post Traumatic Stress Disorder (PTSD)
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

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
  • 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).

    Other Name: Coreg(R)
  • Drug: Placebo
    Non active comparator
  • 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.
    Intervention: Drug: Carvedilol
  • Placebo Comparator: Sugar Pill
    Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
August 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01221792
CVD-PT-10203
No
Arifulla Khan, MD, Columbia Northwest Pharmaceuticals
Columbia Northwest Pharmaceuticals
Not Provided
Study Director: Arifulla Khan, MD Columbia Northwest Pharmaceuticals, LLC
Columbia Northwest Pharmaceuticals
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP