Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder
This study has been completed.
Sponsor:
Central Institute of Mental Health, Mannheim
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
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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:
Drug Information available for:
Hydrocortisone acetate
Hydrocortisone
Hydrocortisone sodium succinate
Hydrocortisone cypionate
Hydrocortisone butyrate
Hydrocortisone valerate
Hydrocortisone probutate
U.S. FDA Resources
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
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 May 19, 2013