Phase 4
N=30
Escitalopram in Patients With Social Anxiety Disorder
Social Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00902226 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I) — 2.1 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Escitalopram (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lundbeck A/S
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I) |
2.1 | — |
| SECONDARY Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S) |
2.6 | — |
| SECONDARY Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2 |
80 | — |
| SECONDARY Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2 |
60 | — |
| SECONDARY Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work |
3.8 | — |
| SECONDARY Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family |
2.2 | — |
| SECONDARY Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social |
3.5 | — |
Summary
The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.
Eligibility Criteria
Inclusion Criteria
- The patient suffers from SAD, diagnosed according to ICD-10 (International Classification of Diseases)
- The patient meets criteria set in the national SPC for escitalopram
- The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs
Exclusion Criteria
- The patient has/has had an alcohol or drug abuse-related disorder, as defined in ICD-10
- The patient has contraindications to escitalopram
- The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram
- The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
- The patient is pregnant or breast-feeding
- The patient, if a woman of childbearing potential, is not using adequate contraception
Data sourced from ClinicalTrials.gov (NCT00902226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.