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Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status and phase

Completed
Phase 1

Conditions

Post-Traumatic Stress Disorder

Treatments

Drug: guanfacine

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00018603
MHBS-047-99F

Details and patient eligibility

About

This is a double-blind, placebo-controlled, randomized study lasting 8 weeks. Purpose of the study is two-fold: first, to use a pharmacological agent to treat symptoms of PTSD, and second, to explore neurobiological mechanisms of action of guanfacine.

Full description

Subject population is comprised of 100 persons with PTSD. 50 patients will receive guanfacine and 50 patients will receive a placebo. Guanfacine is prescribed at 1 mg/day and may be increased to 2 mg/day. Samples of plasma MHPG will be collected weekly. Clinical ratings of PTSD anxiety and depression, as well as vital signs, will be assessed weekly. Repeated measures analysis of variance will assess significance of main effect of drug, time, and drug by time.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • Males and females, age 18-65
  • Diagnosis of PTSD from combat or civilian trauma
  • No major medical problems such as diabetes, cardiovascular disease
  • Taking no psychiatric medication, or taking only one SSRI antidepressant

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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