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

Posttraumatic Stress Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108146
• Other study ID #: HPA-PTSD-1
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: October 2012

Study information

• Verified date: November 2018
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Central Institute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R)		4 Years
Secondary	Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS)		4 Years