Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01108133
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-45
* Female
* Posttraumatic Stress Disorder assessed by the Structured Clinical Interview (SKID-I)
* Intrusive memories (Impact of Events Scale - Revised \[IES-R\] intrusion scale \> 7)
Exclusion Criteria:
* • Lifetime diagnosis schizophrenia according to Diagnostic and Statistical Manual, Fourth Edition (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 Investigational Medicinal Product.
* Following current medication: cardiac glycosides, saluretics, antidiabetics, cumarin-derivatives, rifampicine, phenytoine, barbiturates, primidone, non-steroidal anti-inflammatory drug (NSAID), salicylate and indometacine, atropine, praziquantel, chloroquine, hydroxychloroquine, mefloquine, somatropine, protireline, cyclosporine, non-depolarising muscle relaxants.
* Pregnancy or lactation period
* Inadequate birth control
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01108133
Study Brief:
Protocol Section:
NCT01108133