Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder

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

To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD.

Inclusion Criteria:

• 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)

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 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.