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

Columbia Northwest Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Post-Traumatic Stress Disorder

Treatments: Drug: Placebo; Drug: Carvedilol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01221792

CVD-PT-10203

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

carvedilol

Active Comparator group

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.

Treatment:

Drug: Carvedilol

Sugar Pill

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo