Short Course Glucocorticoid Treatment for PTSD

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this study is to investigate if a 2-wk course of 20mg/day of oral prednisone in addition to standard care will result in reduced PTSD symptoms or symptom severity compared to placebo

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Detailed Description

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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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Prednisone

Prednisone 20mg daily x 2 weeks

Group Type ACTIVE_COMPARATOR

prednisone

Intervention Type DRUG

20mg x 2 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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prednisone

20mg x 2 weeks

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for PTSD w/ symptom exacerbation (CAPS score ≥ 50)
* Stable on other psychotropic meds x1 month

Exclusion Criteria

* Current or past history of bipolar, schizophrenic, or other psychotic disorder
* Organic mental disorder
* Alcohol or substance abuse in last 3 months
* Clinically significant hepatic or renal disease or other acute or unstable medical condition
* Chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes, rheumatologic diseases

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No