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carvedilol for Post-Traumatic Stress Disorder
Phase 2
Waitlist Available
Research Sponsored by Columbia Northwest Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.
Eligible Conditions
- Post-Traumatic Stress Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Davidson Trauma Scale (DTS)
Secondary outcome measures
Clinician Administered PTSD Scale (CAPS)
Insomnia Severity Index (ISI)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: carvedilolActive Control1 Intervention
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 II: Sugar PillPlacebo Group1 Intervention
Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol.
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Who is running the clinical trial?
Columbia Northwest PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
Arifulla Khan, MDStudy DirectorColumbia Northwest Pharmaceuticals, LLC
1 Previous Clinical Trials
80 Total Patients Enrolled
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