Posttraumatic Stress DisorderNCT01108146
Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder
A study testing Arm 1 Hydrocortisone 10 mg and Arm 2 Hydrocortisone 30 mg in people with Posttraumatic Stress Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Arm 1 Hydrocortisone 10 mg and Arm 2 Hydrocortisone 30 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Central Institute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine
Mannheim, 68159
About this study
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)
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
- Being tested
- Arm 1 Hydrocortisone 10 mg, Arm 2 Hydrocortisone 30 mg
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 Hydrocortisone 10 mgDrug
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 mgDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Arm 2 Hydrocortisone 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R)
Measured: 4 Years
Secondary outcomes (1)
Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS)
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startOct 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Christian Schmahl, Central Institute of Mental Health, Mannheim
- Investigators
- Christian Schmahl, MD, Principal investigator, Central Insitute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108146
- Sponsor's protocol ID
- HPA-PTSD-1
- Status last verified
- Nov 2018
- First submitted
- 16 Feb 2010
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26152322
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01108146
- Acronym / sponsor ID
- HPA-PTSD-1
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Oct 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Arm 1 Hydrocortisone 10 mgDrug: 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 |
| Arm 2 | Experimental | Drug: Arm 2 Hydrocortisone 30 mgDrug: 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1 Hydrocortisone 10 mgGroup 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 | Drug | Arm 1 |
| Arm 2 Hydrocortisone 30 mgDrug: 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 |
Primary outcome
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
1 secondary outcome
Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS)
Time frame: 4 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Derived from this study: PubMed 26152322Ludascher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Schmahl, MD principal investigator
Central Insitute of Mental Health, Dpt. of Psychosomatic and Psychotherapeutic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1 Hydrocortisone 10 mg and Arm 2 Hydrocortisone 30 mg in people with Posttraumatic Stress Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01108146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.