Intrusions in patients with posttraumatic stress disorder
Conditions
Interventions
Trade Name: HydrocortisonHOECHST
Product Name: hydrocortisone
Product Code: n.a
Pharmaceutical Form: Capsule*
INN or Proposed INN: hydrocortisone
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Central Institute of Mental Health
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Germany
Outcome results
None listed