Men and women diagnosed with DSM-IV social phobia (social anxiety disorder) MedDRA version: 14.0 Level: LLT Classification code 10041242 Term: Social anxiety disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Cipralex
Product Name: Cipralex
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Uppsala university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Social anxiety disorder (social phobia), according to DSM-IV, must be the main diagnosis as assessed with the structured clinical interview for DSM disorders 2. Otherwise somatically healthy 3. Age 18 or older but not postmenopausal 4. Willingness to participate in a symptom provocation brain imaging trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment of social anxiety within the three months preceding the study 2. Current serious or dominant psychiatric disorder other than social anxiety disorder (e.g., psychosis, major depressive disorder, bipolar disorder) 3. Suicidal ideation 4. Chronic use of prescribed medication that could influence the results 5. Abuse of alcohol or narcotics 6. Pregnancy or planned pregnancy during the study period 7. Menopause 8. Previous PET examination 9. Contrainidications for MRI investigations (e.g. implants or other metal objects in the body, brain and heart operations)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the effect of combined treatment with escitalopram 20mg + cognitive-behavior therapy (CBT), in comparison to CBT+placebo, on brain imaging measures in patients with social anxiety disorder. Specifically we will assess brain activation patterns in response to emotional challenges as assessed with functional magnetic resonance imaging (fMRI), as well as brain dopamine and serotonin transporter availability assessed with positron emission tomography.;Secondary Objective: To examine differences between men and women with regards to treatment outcome and brain measures. To relate differences in brain anatomy and monoamine-associated gene polymorphisms to the outcome measures. Patients will also be compared to a healthy control group before treatment on all measures. ;Primary end point(s): 1. Brain activity as assessed with the fMRI blood oxygen level dependant (BOLD) signal 2. Dopamine transporter availability as assessed with PET and 11C-PE2I 3. Serotonin transporter availability as assessed with PET 4. Clinical outcome as assessed primarily with the Liebowitz Social Anxiety Scale (LSAS) and the Clinical Global Impression - Improvement (CGI-I) scale | — |
Countries
Sweden
Outcome results
None listed