Glucocorticoid Treatment for Social Phobia

NCT01574014 | Terminated Phase 2

• 3 other identifiers: 161/0732003B_1249472008DR2002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phobic Disorders; Phobias

Keywords

Anxiety Disorder; Phobic Disorders

Outcome Measures

Primary Outcomes (1)

• Change from baseline in spider phobia symptoms / social phobia symptoms

  measured by various standardized questionnaires

  at follow-up visit, expected to be after 3 months

Secondary Outcomes (3)

• Change from baseline in state and trait anxiety

  1-3 weeks before treatment, 4 weeks after treatment, 3 months after treatment

• Change from baseline in personality traits

  1-3 weeks before treatment

• Change from baseline in amygdala activation

  1-3 weeks before treatment, 4 weeks after treatment

Study Arms (2)

1: CBGT & Hydrocortisone

ACTIVE COMPARATOR

Behavioral: CBGT; Drug: Hydrocortisone

2: CBGT & Placebo

PLACEBO COMPARATOR

Behavioral: CBGT; Drug: Placebo

Interventions

CBGT BEHAVIORAL

Cognitive-behavioral group therapy

1: CBGT & Hydrocortisone; 2: CBGT & Placebo

Hydrocortisone DRUG

3 x 20 mg Hydrocortisone (oral, 60 min. before MRI1, 60 min. before exposition in CBGT1 and 60 min. before exposition in CBGT2)

1: CBGT & Hydrocortisone

Placebo DRUG

Placebo (oral, 60 min. before MRI1, 60 min. before exposition in CBGT1 and 60 min. before exposition in CBGT2)

2: CBGT & Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Other Psychiatric Disorder / Comorbidities
• Smoking more than 15 cigarettes per day
• Medication
• Contraceptives
• Physical illness
• Neurological disease
• Drug abuse

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Basel: collaborator

Study Sites (1)

Dep. of Psychiatric Neurophysiology, University Hospital of Psychiatry, University of Bern

Bern, 3060, Switzerland

Location

Related Publications (5)

• Soravia LM, de Quervain DJ, Heinrichs M. Glucocorticoids do not reduce subjective fear in healthy subjects exposed to social stress. Biol Psychol. 2009 Jul;81(3):184-8. doi: 10.1016/j.biopsycho.2009.04.001. Epub 2009 Apr 11.

  PMID: 19482235 BACKGROUND

• de Quervain DJ, Roozendaal B, Nitsch RM, McGaugh JL, Hock C. Acute cortisone administration impairs retrieval of long-term declarative memory in humans. Nat Neurosci. 2000 Apr;3(4):313-4. doi: 10.1038/73873. No abstract available.

  PMID: 10725918 BACKGROUND

• de Quervain DJ, Roozendaal B, McGaugh JL. Stress and glucocorticoids impair retrieval of long-term spatial memory. Nature. 1998 Aug 20;394(6695):787-90. doi: 10.1038/29542.

  PMID: 9723618 BACKGROUND

• 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.

  PMID: 15285979 BACKGROUND

• Soravia LM, Schwab S, Weber N, Nakataki M, Wiest R, Strik W, Heinrichs M, de Quervain D, Federspiel A. Glucocorticoid administration restores salience network activity in patients with spider phobia. Depress Anxiety. 2018 Oct;35(10):925-934. doi: 10.1002/da.22806. Epub 2018 Aug 12.

  PMID: 30099829 DERIVED

MeSH Terms

Conditions

Phobic Disorders; Anxiety Disorders

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Leila M Soravia, PhD

  Department of Psychiatric Neurophysiology, University Hospital of Psychiatry, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: April 10, 2012
• Study Start: July 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

CH (1)