Monocentric, Double-blind Placebo-Controlled, Randomized Cross-Sectional Clinical Trial of Hydrocortisone (10 and 30mg/d) in Outpatients with Posttraumatic-Stress- Disorder (PTSD) - Hydrocortisone in the Treatment of Intrusions in Patients with PTSD

• Conditions: Intrusions in patients with posttraumatic stress disorder

• Registration Number: EUCTR2007-004286-18-DE
• Lead Sponsor: Central Institute of Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-20
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•Written Informed Consent
•Female patients with PTSD according to DSM-IV criteria
•18-45 years
•Intrusions (according to IES-R subscale Intrusions: Value: > 7
•Ability of subject to understand character and individual consequences of
the clinical trial
•No participation in another clinical trial (up from 30 days before this trial)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Lifetime diagnosis schizophrenia according to DSM-IV
•Mental retardation
•Body mass index < 16.5
•Current drug and alcohol abuse and addiction
•Life-threatening self-injurious behavior in the last 4 months
•Suicide attempt with the strong intention to die in the last 4 months.
•Following diseases in anamnesis: stomach ulcera or intestinal ulcera,
pancreatitis, corticoid-induced psychosis, severe osteoporosis, severe
hypertension, heart failure, myasthenia gravis, asthma bronchiale,
glaucoma, cataract, diabetes mellitus, herpes simples, herpes zoster
(viremic phase), renal transplantation.
•Following current medication: cardiac glycosides, saluretics, antidiabetics,
cumarin-derivatives, rifampicine, phenytoine, barbiturates, primidone,
NSAID, salicylate and indometacine, atropine, praziquantel, chloroquine,
hydroxychloroquine, mefloquine, somatropine, protireline, cyclosporine,
non-depolarising muscle relaxants.
•Any pretreatment with hydrocortisone in the last 4 weeks prior to the first administration of the investigational medicinal product.
•Shift working
•Intercontinal travel within 2 weeks prior to enrolment (to avoid jet-lag)
•Pregnancy or lactation period
•Inadequate birth control (Adequate birth control: implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner)
•History of hypersensitivity to investigational medicinal product or to any
drug with similar chemical structure or to any excipient present in the
pharmaceutical form of the investigational medicinal product.
•No subject will be allowed to enrol in this trial more than once.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD;Secondary Objective: To explore whether the efficacy of hydrocortisone depends on the daily dose;Primary end point(s): Primary efficacy endpoint: Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R)<br>