Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Central Institute of Mental Health, Mannheim
With
German Research Foundation
Age
18–45
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Written Informed Consent
Female patients with PTSD according to DSM-IV criteria (see Appendix 2).
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)
You may not be if
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 hyper-tension, heart failure, myasthenia gravis, asthma bronchiale, glaucoma, cataract, diabetes mellitus, herpes simples, herpes zoster (viremic phase), renal transplantation.
Any pretreatment with hydrocortisone in the last 4 weeks prior to the first administration of Investiga-tional Medicinal Product.
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.
Pregnancy or lactation period
Inadequate birth control (Adequate birth control: implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner)
Shift working
Intercontinental travel within 2 weeks prior to enrollment (to avoid jet-lag)
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.
Clareo Health | Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder