Clinical Trial: Glucocorticoid Treatment for Social Phobia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Glucocorticoid Treatment for Social Phobia

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.

Detailed Summary:

Background

Anxiety disorders have major public health significance and social phobia ranks as the third most common mental health disorder after depression and alcoholism. Even though cognitive-behavioral therapy (CBT) is the most effective non-pharmacological approach to the treatment of social phobia, more than one third of the patients do not respond to treatment, or achieve only partial remission of symptoms. Pharmacotherapy (e.g., SSRIs, benzodiazepines) has been shown to be effective in the acute treatment of social phobia, however, with high rates of relapse when medication is discontinued. In addition, the combination of CBT and medication does not seem to be more beneficial than CBT alone. Consequently, the development of innovative psychobiological approaches combining effective psychotherapy methods with synergizing substance administration is a primary challenge in interdisciplinary research on treatment of social phobia.

In a recent study the investigators found evidence that a pharmacological elevation of glucocorticoid levels reduces fear in patients with social phobia and spider phobia exposed to a phobic stimulus. Furthermore, the investigators have shown that repeated administration of glucocorticoids before exposure to a phobic stimulus leads to an extinction of phobic fear. Also the low-dose administration of cortisone over a month in patients with post-traumatic stress disorder reduces cardinal of symptoms the disorder. Based on these findings, glucocorticoid treatment, in combination with exposure therapy, may help to reduce fear and promote extinction of phobic fear.

In an interdisciplinary research project involving psychology, behavioral pharmacology psychiatry, genetics and neuroimaging the investigators propose to investigate the therapeutic effic
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: Change from baseline in spider phobia symptoms / social phobia symptoms [ Time Frame: at follow-up visit, expected to be after 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change from baseline in state and trait anxiety [ Time Frame: 1-3 weeks before treatment, 4 weeks after treatment, 3 months after treatment ]
  measured by standardized questionnaires
• Change from baseline in personality traits [ Time Frame: 1-3 weeks before treatment ]
  measured by standardized questionnaires
• Change from baseline in amygdala activation [ Time Frame: 1-3 weeks before treatment, 4 weeks after treatment ]
  measured by several magnetic resonance sequences

Original Secondary Outcome: Same as current

Information By: University Hospital Inselspital, Berne

Dates:
Date Received: March 14, 2012
Date Started: July 2009
Date Completion:
Last Updated: December 4, 2012
Last Verified: December 2012