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

NCT ID: NCT01221792

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-08-31

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

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Carvedilol

Intervention Type: 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).

Sugar Pill

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Non active comparator

Interventions

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).

Intervention Type: DRUG

Placebo

Non active comparator

Intervention Type: DRUG

Other Intervention Names

Coreg(R)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia Northwest Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Columbia Northwest Pharmaceuticals

Principal Investigators

Arifulla Khan, MD

Role: STUDY_DIRECTOR

Columbia Northwest Pharmaceuticals, LLC

Locations

Artemis Institute for Clinical Research

San Diego, California, United States

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Countries

United States

Other Identifiers

CVD-PT-10203

Identifier Type: -

Identifier Source: org_study_id