Escitalopram in Patients With Generalized Anxiety Disorder
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.
Full description
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- The patient suffers from GAD, diagnosed according to ICD-10 (International Classification of Diseases)
- The patient meets criteria as set out 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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