NCT00451750

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

2.3 years

First QC Date

March 21, 2007

Last Update Submit

January 11, 2010

Conditions

Phobia

Keywords

phobiacortisolmemorytreatment

Outcome Measures

Primary Outcomes (1)

  • visual analog scales for fear and acrophobia questionnaires

    1 month

Interventions

CortisolDRUG

20 mg for 3 times

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Female and male patients with a specific phobia (fear of heights) according to DSM-IV criteria.

You may not qualify if:

  • Severe acute or chronic somatic diseases
  • Psychiatric disorder other than specific phobia
  • Topic glucocorticoid therapy (for large skin parts)
  • Inhaled glucocorticoids
  • Psychotropic medication
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel

Basel, 4055, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 16567641BACKGROUND

MeSH Terms

Conditions

Phobic Disorders

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Dominique JF de Quervain, MD, Prof.

    University of Zurich

    PRINCIPAL INVESTIGATOR

  • Frank Wilhelm, Prof.

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Study Start

May 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

CH(1)