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

Sponsor

Columbia Northwest Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01221792

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

26.7

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorder	Drug: Carvedilol Drug: Placebo	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Artemis Institute for Clinical Research	San Diego	California	United States	92123
2	Lake Charles Clinical Trials	Lake Charles	Louisiana	United States	70601
3	Northwest Clinical Research Center	Bellevue	Washington	United States	98007