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

NCT01108146 | Completed DMC

• 1 other identifier: HPA-PTSD-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

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

  4 Years

Secondary Outcomes (1)

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

  4 Years

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

EXPERIMENTAL

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

Interventions

Arm 1 Hydrocortisone 10 mg DRUG

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 1

Arm 2 Hydrocortisone 30 mg DRUG

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

Arm 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written Informed Consent
• Female patients with PTSD according to DSM-IV criteria (see Appendix 2).
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead
• German Research Foundation: collaborator

Study Sites (1)

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

Mannheim, 68159, Germany

Location

Related Publications (1)

• Ludascher P, Schmahl C, Feldmann RE Jr, Kleindienst N, Schneider M, Bohus M. No evidence for differential dose effects of hydrocortisone on intrusive memories in female patients with complex post-traumatic stress disorder--a randomized, double-blind, placebo-controlled, crossover study. J Psychopharmacol. 2015 Oct;29(10):1077-84. doi: 10.1177/0269881115592339. Epub 2015 Jul 6.

  PMID: 26152322 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Christian Schmahl, MD

  Central Insitute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: April 21, 2010
• Study Start: October 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

DE (1)