Posttraumatic Stress DisorderNCT00362661
Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
A study testing Cortisol in people with Posttraumatic Stress Disorder, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of this prospective, double-blind, placebo-controlled, cross-over study is to determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic stress disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Cortisol
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2007to Dec 2009
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female and male patients with chronic PTSD due to adult trauma; PTSD is diagnosed according to the DSM-IV, as measured with the CAPS
- Age between 18 and 60
Who cannot join
- History of disease states representing contraindications to glucocorticoid therapy (tuberculosis, gastritis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy (to exclude with a pregnancy test) and lactation, glaucoma, diabetes mellitus, thrombophilia, acute or chronic infections, hyperthyroidism, cirrhosis)
- Severe or chronic somatic diseases
- Topic glucocorticoid therapy (for large skin parts)
- Inhaled glucocorticoids
- Current psychotic, bipolar, substance-related, or severe personality disorder
- Current severe depressive disorder
Show all 12Show fewer
- Severe cognitive impairment or a history of organic mental disorder
- Evidence of PTSD or depression immediately prior to the index trauma
- Prominent current suicidal or homicidal ideation
- Asylum seeking status
- Body weight >20% above or below normal range
- Changes in psychopharmacologic or psychotherapeutic management less than 8 weeks before start of the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Psychiatry, University Hospital Zurich
Zurich, 8091
About this study
The aim of this prospective, double-blind, placebo-controlled, cross-over study is to determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic stress disorder.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Cortisol
- Keywords
- PTSD, cortisol, memory, treatment
- 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.
CortisolDrug
Also called Cortisol (10 mg), Galepharm, Küsnacht, Switzerland
Cortisol 10 mg/d for 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS CGI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Recruitment: Insufficient number of patients eligible for enrollment
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.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Dominique de Quervain, MD, Principal investigator, Division of Psychiatry Research, University of Zurich, Lenggstr. 31, 8032 Zurich, SwitzerlandUlrich Schnyder, MD, Principal investigator, Department of Psychiatry, University Hospital Zurich, Culmannstrasse 8, 8091 Zürich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362661
- Sponsor's protocol ID
- PTSD-06
- Status last verified
- Jan 2010
- First submitted
- 9 Aug 2006
- Last updated
- 12 Jan 2010
- Results posted
- No
Publications
Aerni A, Traber R, Hock C, Roozendaal B, Schelling G, Papassotiropoulos A, Nitsch RM, Schnyder U, de Quervain DJ. Low-dose cortisol for symptoms of posttraumatic stress disorder. Am J Psychiatry. 2004 Aug;161(8):1488-90. doi: 10.1176/appi.ajp.161.8.1488.
PubMed 15285979
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00362661
- Acronym / sponsor ID
- PTSD-06
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, cortisol, memory, treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment: Insufficient number of patients eligible for enrollment
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Aug 2006 (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.
The aim of this prospective, double-blind, placebo-controlled, cross-over study is to determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic stress disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female and male patients with chronic PTSD due to adult trauma; PTSD is diagnosed according to the DSM-IV, as measured with the CAPS
- Age between 18 and 60
Key exclusion criteria (12 listed)
- History of disease states representing contraindications to glucocorticoid therapy (tuberculosis, gastritis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy (to exclude with a pregnancy test) and lactation, glaucoma, diabetes mellitus, thrombophilia, acute or chronic infections, hyperthyroidism, cirrhosis)
- Severe or chronic somatic diseases
- Topic glucocorticoid therapy (for large skin parts)
- Inhaled glucocorticoids
- Current psychotic, bipolar, substance-related, or severe personality disorder
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 |
|---|---|---|
| CortisolAlso: Cortisol (10 mg), Galepharm, Küsnacht, SwitzerlandCortisol 10 mg/d for 3 months | Drug | – |
Primary outcome
CAPS CGI
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Recruitment: Insufficient number of patients eligible for enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Background: PubMed 15285979Aerni A, Traber R, Hock C, Roozendaal B, Schelling G, Papassotiropoulos A, Nitsch RM, Schnyder U, de Quervain DJ. Low-dose cortisol for symptoms of posttraumatic stress disorder. Am J Psychiatry. 2004 Aug;161(8):1488-90. doi: 10.1176/appi.ajp.161.8.1488.
Related trials for Posttraumatic Stress Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Not yet recruitingPhase 2
Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
PTSD - Post Traumatic Stress Disorder
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Recruiting
Evaluating Evidenced Based Options for PTSD Treatment
PTSD - Post Traumatic Stress Disorder
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.
Dominique de Quervain, MD principal investigator
Division of Psychiatry Research, University of Zurich, Lenggstr. 31, 8032 Zurich, Switzerland
Ulrich Schnyder, MD principal investigator
Department of Psychiatry, University Hospital Zurich, Culmannstrasse 8, 8091 Zürich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cortisol in people with Posttraumatic Stress Disorder, run by University of Zurich at 1 site in Switzerland.
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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 12 Jan 2010. 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 Switzerland. 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 was stopped early (reason given: Recruitment: Insufficient number of patients eligible for enrollment). Results are not available in the source record.
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?
CAPS CGI (time frame: 1 year). 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 NCT00362661, 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 12 Jan 2010.