E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Men and women diagnosed with DSM-IV social phobia (social anxiety disorder) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041242 |
E.1.2 | Term | Social anxiety disorder |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The drug regiment ends after nine weeks of treatment. The full trial will end with the completion of the questionnaires at 12-month follow-up. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |