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

NCT ID: NCT00018603

Last Updated: 2009-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-30

Study Completion Date

2002-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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guanfacine

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Locations

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VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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MHBS-047-99F

Identifier Type: -

Identifier Source: org_study_id

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