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

November 19, 2018 updated by: Christian Schmahl, Central Institute of Mental Health, Mannheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68159
        • Central Institute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 Years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Christian Schmahl, MD, Central Insitute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Actual)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPA-PTSD-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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