This trial is active, not recruiting.

Condition post-traumatic stress disorder
Treatments carvedilol, placebo
Phase phase 2
Sponsor Columbia Northwest Pharmaceuticals
Start date October 2010
End date June 2011
Trial size 80 participants
Trial identifier NCT01221792, CVD-PT-10203


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
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.
carvedilol Coreg(R)
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).
(Placebo Comparator)
Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol.
Non active comparator

Primary Outcomes

Davidson Trauma Scale (DTS)
time frame: 5 weeks

Secondary Outcomes

Clinician Administered PTSD Scale (CAPS)
time frame: 6 Weeks
Insomnia Severity Index (ISI)
time frame: 5 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Columbia Northwest Pharmaceuticals.