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
  Purpose

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


Condition Intervention
Posttraumatic Stress Disorder
Drug: Arm 1 Hydrocortisone 10 mg
Drug: Arm 2 Hydrocortisone 30 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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)

Resource links provided by NLM:


Further study details as provided by Central Institute of Mental Health, Mannheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: October 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

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


  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108146

Locations
Germany
Central Institute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine
Mannheim, Germany, 68159
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
German Research Foundation
Investigators
Principal Investigator: Christian Schmahl, MD Central Insitute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine
  More Information

No publications provided

Responsible Party: Petra Ludaescher, Dr., Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT01108146     History of Changes
Other Study ID Numbers: HPA-PTSD-1
Study First Received: February 16, 2010
Last Updated: January 29, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on July 23, 2014