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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Columbia Northwest Pharmaceuticals.
Recruitment status was  Active, not recruiting
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
  Purpose

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


Condition Intervention Phase
Post-Traumatic Stress Disorder
Drug: Carvedilol
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Columbia Northwest Pharmaceuticals:

Primary Outcome Measures:
  • 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).



Secondary Outcome Measures:
  • 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)



Estimated Enrollment: 80
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)
Arms Assigned Interventions
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.
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)
Placebo Comparator: Sugar Pill
Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol.
Drug: Placebo
Non active comparator

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221792

Locations
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
Sponsors and Collaborators
Columbia Northwest Pharmaceuticals
Investigators
Study Director: Arifulla Khan, MD Columbia Northwest Pharmaceuticals, LLC
  More Information

No publications provided

Responsible Party: Arifulla Khan, MD, Columbia Northwest Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01221792     History of Changes
Other Study ID Numbers: CVD-PT-10203
Study First Received: October 14, 2010
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia Northwest Pharmaceuticals:
PTSD
Anxiety
Trauma
Assault
Victim
Witness
Post Traumatic Stress Disorder
Combat veteran
Flashbacks
Nightmares
Sleep Disturbance
Hyperarousal
Numbness
Avoidance

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on April 23, 2014