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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Institute of Mental Health, Mannheim
• Collaborator: German Research Foundation
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Polystyrene sulfonic acid

Criteria

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.