PhobiaNCT00451750
Cortisol in the Treatment of Phobias
A study testing Cortisol in people with Phobia, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of this prospective, double-blind, placebo-controlled, randomized study is to investigate if glucocorticoid treatment, in combination with exposure therapy, helps to reduce phobic fear in patients with phobia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Phobia
- What is being tested?
- Cortisol
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2007to Sep 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female and male patients with a specific phobia (fear of heights) according to DSM-IV criteria.
Who cannot join
- Severe acute or chronic somatic diseases
- Psychiatric disorder other than specific phobia
- Topic glucocorticoid therapy (for large skin parts)
- Inhaled glucocorticoids
- Psychotropic medication
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Cortisol in Combination With Behavioral Therapy in the Treatment of Phobias
The aim of this prospective, double-blind, placebo-controlled, randomized study is to investigate if glucocorticoid treatment, in combination with exposure therapy, helps to reduce phobic fear in patients with phobia.
- Conditions
- Phobia
- Being tested
- Cortisol
- Keywords
- phobia, cortisol, memory, treatment
- Medical subject headings
- Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CortisolDrug
20 mg for 3 times
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scales for fear and acrophobia questionnaires
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2009
- Study completionSep 2009
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 PhobiaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Investigators
- Dominique JF de Quervain, MD, Prof., Principal investigator, University of ZurichFrank Wilhelm, Prof., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451750
- Sponsor's protocol ID
- 2007DR3069
- Status last verified
- Jan 2010
- First submitted
- 21 Mar 2007
- Last updated
- 12 Jan 2010
- Results posted
- No
Publications
Soravia LM, Heinrichs M, Aerni A, Maroni C, Schelling G, Ehlert U, Roozendaal B, de Quervain DJ. Glucocorticoids reduce phobic fear in humans. Proc Natl Acad Sci U S A. 2006 Apr 4;103(14):5585-90. doi: 10.1073/pnas.0509184103. Epub 2006 Mar 27.
PubMed 16567641
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
- The Efficacy of Cortisol in Combination With Behavioral Therapy in the Treatment of Phobias
- ClinicalTrials.gov ID
- NCT00451750
- Acronym / sponsor ID
- 2007DR3069
- Conditions
- Phobia
- Keywords
- phobia, cortisol, memory, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- May 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Mar 2007 (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, randomized study is to investigate if glucocorticoid treatment, in combination with exposure therapy, helps to reduce phobic fear in patients with phobia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female and male patients with a specific phobia (fear of heights) according to DSM-IV criteria.
Key exclusion criteria (6 listed)
- Severe acute or chronic somatic diseases
- Psychiatric disorder other than specific phobia
- Topic glucocorticoid therapy (for large skin parts)
- Inhaled glucocorticoids
- Psychotropic medication
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 |
|---|---|---|
| Cortisol20 mg for 3 times | Drug | – |
Primary outcome
visual analog scales for fear and acrophobia questionnaires
Time frame: 1 month
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 12 Jan 2010.
- Background: PubMed 16567641Soravia LM, Heinrichs M, Aerni A, Maroni C, Schelling G, Ehlert U, Roozendaal B, de Quervain DJ. Glucocorticoids reduce phobic fear in humans. Proc Natl Acad Sci U S A. 2006 Apr 4;103(14):5585-90. doi: 10.1073/pnas.0509184103. Epub 2006 Mar 27.
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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.
Dominique JF de Quervain, MD, Prof. principal investigator
University of Zurich
Frank Wilhelm, Prof. principal investigator
University of Basel
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 Phobia, 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 1 inclusion and 6 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 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 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?
visual analog scales for fear and acrophobia questionnaires (time frame: 1 month). 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 NCT00451750, 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.