Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder
Not Applicable
Completed
- Conditions
- Posttraumatic Stress Disorder
- Interventions
- Registration Number
- NCT01108146
- Lead Sponsor
- Central Institute of Mental Health, Mannheim
- Brief Summary
To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1 Arm 1 Hydrocortisone 10 mg 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 Arm 2 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS) 4 Years
Trial Locations
- Locations (1)
Central Institute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine
🇩🇪Mannheim, Germany