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

Primary Purpose

Posttraumatic Stress Disorder

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Arm 1 Hydrocortisone 10 mg

Arm 2 Hydrocortisone 30 mg

About this trial

This is an interventional basic science trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

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: 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01108146

First Posted

February 16, 2010

Last Updated

November 19, 2018

Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

German Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01108146

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

German Research Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Arm 1 Hydrocortisone 10 mg

Intervention Description

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

Intervention Name(s)

Arm 2 Hydrocortisone 30 mg

Intervention Description

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

4 Years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Schmahl, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Mannheim

ZIP/Postal Code

68159

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

26152322

Citation

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.

Results Reference

derived

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

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