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

NCT ID: NCT01108146

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Arm 1 Hydrocortisone 10 mg

Intervention Type: 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 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

Group Type: EXPERIMENTAL

Arm 2 Hydrocortisone 30 mg

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Christian Schmahl

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Schmahl, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Mannheim, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 26152322 (View on PubMed)

Other Identifiers

HPA-PTSD-1

Identifier Type: -

Identifier Source: org_study_id