Trial | NCT01108146  Report issue

Title

Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder
Monocentric, Double-blind Placebo-Controlled, Randomized Cross-Sectional Clinical Trial of Hydrocortisone (10 and 30 mg/d) in Outpatients With Posttraumatic-Stress-Disorder (PTSD)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urea ...

  • Study Participants

    30
To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD.
Study Started
Oct 31
2008
Primary Completion
Oct 31
2012
Study Completion
Oct 31
2012
Last Update
Nov 21
2018

Drug Arm 1 Hydrocortisone 10 mg

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

Drug Arm 2 Hydrocortisone 30 mg

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

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

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

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.
No Results Posted