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

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

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

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Arm 1 Hydrocortisone 10 mg
* Drug: Arm 2 Hydrocortisone 30 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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<br>* 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<br>|
| Experimental: Arm 2<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R) |  | 4 Years | 

Secondary Outcome Measures

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