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Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Petra Ludaescher, Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT01108146
First received: February 16, 2010
Last updated: January 29, 2013
Last verified: January 2013
History of Changes

February 16, 2010
January 29, 2013
October 2008
October 2012   (final data collection date for primary outcome measure)
Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R) [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01108146 on ClinicalTrials.gov Archive Site
Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS) [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Posttraumatic Stress Disorder
  • 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
  • Experimental: Arm 1

    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

    Intervention: Drug: Arm 1 Hydrocortisone 10 mg
  • Experimental: Arm 2

    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

    Intervention: Drug: Arm 2 Hydrocortisone 30 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01108146
HPA-PTSD-1
Yes
Petra Ludaescher, Central Institute of Mental Health, Mannheim
Central Institute of Mental Health, Mannheim
German Research Foundation
Principal Investigator: Christian Schmahl, MD Central Insitute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine
Central Institute of Mental Health, Mannheim
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP