CClinicalTrials.gg
Sign In
CompletedNCT01108146Updated Nov 21, 2018

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

An interventional study of Arm 1 Hydrocortisone 10 mg and Arm 2 Hydrocortisone 30 mg in Posttraumatic Stress Disorder, sponsored by Central Institute of Mental Health, Mannheim. Completed at 1 site in Germany. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-11-21.

Sponsored by Central Institute of Mental Health, Mannheim · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Posttraumatic Stress Disorder
03

In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

Central Institute of Mental Health, Mannheim is the lead sponsor of 59 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugArm 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

  • DrugArm 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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS)

    Time frame: 4 Years

07

Study locations

1 site
  • Central Institute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine
    Mannheim, 68159, Germany
08

References and documents

Publications

  • 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. PubMed 26152322 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01108146
Lead sponsor
Central Institute of Mental Health, Mannheim
Collaborators
German Research Foundation
Responsible party
Christian Schmahl (Prof. Dr., Central Institute of Mental Health, Mannheim) — Principal investigator
First posted
Apr 21, 2010
Start date
Oct 2008
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Nov 21, 2018

Study contacts

Christian Schmahl, MD
principal investigator · Central Insitute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stress Disorders, Traumatic→

Other studies from this sponsor

Central Institute of Mental Health, Mannheim

Start the discussion