Glucocorticoid Treatment for Social Phobia

This study has been terminated.
(Recruiting problems)
Sponsor:
Collaborator:
University of Basel
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01574014
First received: March 14, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

Social phobia is the third most common psychiatric disorder besides depression and alcoholism. Several studies have demonstrated the efficacy of cognitive-behavioral therapy in the treatment of social phobia. Nevertheless, there is no effect in a third of the people at the existing treatment methods. Pharmacological therapies have similar effects, but there is a high rate of relapse after discontinuation of medication.

Social phobia is characterized by fear of performance or interaction situations. The strong fear of negative evaluation by others is usually accompanied by a marked avoidance behavior and increased physical symptoms such as blushing, sweating, palpitations, or tremors. The confrontation with a phobic stimulus leads to a retrieval of stimulus-associated aversive memories, resulting in an immediate anxiety response. Several studies had already shown that elevated glucocorticoids impair retrieval of declarative memory contents in healthy subjects. The investigators demonstrated an anxiety-reducing effect after the administration of cortisone before the confrontation with a phobic stimulus in patients with social and spider phobia.


Condition Intervention Phase
Phobic Disorders
Phobias
Behavioral: CBGT
Drug: Hydrocortisone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Glucocorticoid Treatment for Social Phobia

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Change from baseline in spider phobia symptoms / social phobia symptoms [ Time Frame: at follow-up visit, expected to be after 3 months ] [ Designated as safety issue: No ]
    measured by various standardized questionnaires


Secondary Outcome Measures:
  • Change from baseline in state and trait anxiety [ Time Frame: 1-3 weeks before treatment, 4 weeks after treatment, 3 months after treatment ] [ Designated as safety issue: No ]
    measured by standardized questionnaires

  • Change from baseline in personality traits [ Time Frame: 1-3 weeks before treatment ] [ Designated as safety issue: No ]
    measured by standardized questionnaires

  • Change from baseline in amygdala activation [ Time Frame: 1-3 weeks before treatment, 4 weeks after treatment ] [ Designated as safety issue: No ]
    measured by several magnetic resonance sequences


Enrollment: 66
Study Start Date: July 2009
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1: CBGT & Hydrocortisone Behavioral: CBGT
Cognitive-behavioral group therapy
Drug: Hydrocortisone
3 x 20 mg Hydrocortisone (oral, 60 min. before MRI1, 60 min. before exposition in CBGT1 and 60 min. before exposition in CBGT2)
Placebo Comparator: 2: CBGT & Placebo Behavioral: CBGT
Cognitive-behavioral group therapy
Drug: Placebo
Placebo (oral, 60 min. before MRI1, 60 min. before exposition in CBGT1 and 60 min. before exposition in CBGT2)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age (20-55)
  • Spider Phobia
  • Right Handed
  • Social Phobia

Exclusion Criteria:

  • Other Psychiatric Disorder / Comorbidities
  • Smoking more than 15 cigarettes per day
  • Medication
  • Contraceptives
  • Physical illness
  • Neurological disease
  • Drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574014

Locations
Switzerland
Dep. of Psychiatric Neurophysiology, University Hospital of Psychiatry, University of Bern
Bern, Switzerland, 3060
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Basel
Investigators
Principal Investigator: Leila M Soravia, PhD Department of Psychiatric Neurophysiology, University Hospital of Psychiatry, University of Bern
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01574014     History of Changes
Other Study ID Numbers: 161/07, 32003B_124947, 2008DR2002
Study First Received: March 14, 2012
Last Updated: December 4, 2012
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
Anxiety Disorder
Phobic Disorders

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Glucocorticoids
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Dermatologic Agents

ClinicalTrials.gov processed this record on August 21, 2014