Clinical trial NCT01108146: Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder
Official title: Monocentric, Double-blind Placebo-Controlled, Randomized Cross-Sectional Clinical Trial of Hydrocortisone (10 and 30 mg/d) in Outpatients With Posttraumatic-Stress-Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2010-04-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
measure: Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R)
timeFrame: 4 Years
Secondary outcomes:
measure: Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS)
timeFrame: 4 Years
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine
Study officials:
affiliation: Central Insitute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine
name: Christian Schmahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.