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

Condition(s) targeted: Posttraumatic Stress Disorder

Intervention: Arm 1 Hydrocortisone 10 mg (Drug); Arm 2 Hydrocortisone 30 mg (Drug)

Phase: N/A

Status: Completed

Sponsored by: Central Institute of Mental Health, Mannheim

Official(s) and/or principal investigator(s):
Christian Schmahl, MD, Principal Investigator, Affiliation: Central Insitute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R)

Secondary outcome: Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS)

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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.

Central Institute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine, Mannheim 68159, Germany

Starting date: October 2008
Last updated: January 29, 2013