Hydrocortisone in the Treatment of Intrusions in Patients... | NCT01108146

NCT01108146

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Name	Class
German Research Foundation	OTHER

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Drug: Hydrocortisone 10 mg Group 1: Administration of Hydrocortisone and/or Placebo in the following order: 1 week placebo-1 week hydrocortisone 10 mg/d -1 week placebo - 1 week hydrocortisone 30 mg/d	Drug: Arm 1 Hydrocortisone 10 mg
Arm 2	Experimental	Drug: Hydrocortisone 30 mg Group 2: Administration of Hydrocortisone and/or Placebo in the following order: 1 week hydrocortisone 30 mg/d- 1 week placebo - 1 week hydrocortisone 10 mg/d - 1 week placebo	Drug: Arm 2 Hydrocortisone 30 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arm 1 Hydrocortisone 10 mg	Drug	Group 1: Administration of Hydrocortisone and/or Placebo in the following order: 1 week placebo- 1 week 10 mg hydrocortisone - 1 week placebo - 1 week 30 mg hydrocortisone

Measure	Description	Time Frame
Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R)		4 Years

Measure	Description	Time Frame
Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS)		4 Years

Eligibility Module

Eligibility 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.

Name	Affiliation	Role
Christian Schmahl, MD	Central Insitute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Central Institute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine		Mannheim		68159	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26152322	Derived	Ludascher P, Schmahl C, Feldmann RE Jr, Kleindienst N, Schneider M, Bohus M. No evidence for differential dose effects of hydrocortisone on intrusive memories in female patients with complex post-traumatic stress disorder--a randomized, double-blind, placebo-controlled, crossover study. J Psychopharmacol. 2015 Oct;29(10):1077-84. doi: 10.1177/0269881115592339. Epub 2015 Jul 6.

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders