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

Primary Purpose

Post-Traumatic Stress Disorder

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carvedilol
Placebo
Sponsored by
Columbia Northwest Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Anxiety, Trauma, Assault, Victim, Witness, Post Traumatic Stress Disorder, Combat veteran, Flashbacks, Nightmares, Sleep Disturbance, Hyperarousal, Numbness, Avoidance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Artemis Institute for Clinical Research
  • Lake Charles Clinical Trials
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

carvedilol

Sugar Pill

Arm Description

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.

Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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)

Full Information

First Posted
October 14, 2010
Last Updated
June 6, 2011
Sponsor
Columbia Northwest Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01221792
Brief Title
Carvedilol Versus Placebo for Treatment in Post Traumatic Stress Disorder (PTSD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Columbia Northwest Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Anxiety, Trauma, Assault, Victim, Witness, Post Traumatic Stress Disorder, Combat veteran, Flashbacks, Nightmares, Sleep Disturbance, Hyperarousal, Numbness, Avoidance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
carvedilol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol.
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
Coreg(R)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Non active comparator
Primary Outcome Measure Information:
Title
Davidson Trauma Scale (DTS)
Description
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).
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
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.
Time Frame
6 Weeks
Title
Insomnia Severity Index (ISI)
Description
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)
Time Frame
5 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arifulla Khan, MD
Organizational Affiliation
Columbia Northwest Pharmaceuticals, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

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

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