Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

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

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-12-31

Brief Summary

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The aim of this prospective, double-blind, placebo-controlled, cross-over study is to determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic stress disorder.

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Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Cortisol

Cortisol 10 mg/d for 3 months

Intervention Type DRUG

Other Intervention Names

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Cortisol (10 mg), Galepharm, Küsnacht, Switzerland

Eligibility Criteria

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Inclusion Criteria

* Female and male patients with chronic PTSD due to adult trauma; PTSD is diagnosed according to the DSM-IV, as measured with the CAPS
* Age between 18 and 60

Exclusion Criteria

* History of disease states representing contraindications to glucocorticoid therapy (tuberculosis, gastritis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy (to exclude with a pregnancy test) and lactation, glaucoma, diabetes mellitus, thrombophilia, acute or chronic infections, hyperthyroidism, cirrhosis)
* Severe or chronic somatic diseases
* Topic glucocorticoid therapy (for large skin parts)
* Inhaled glucocorticoids
* Current psychotic, bipolar, substance-related, or severe personality disorder
* Current severe depressive disorder
* Severe cognitive impairment or a history of organic mental disorder
* Evidence of PTSD or depression immediately prior to the index trauma
* Prominent current suicidal or homicidal ideation
* Asylum seeking status
* Body weight \>20% above or below normal range
* Changes in psychopharmacologic or psychotherapeutic management less than 8 weeks before start of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No