Status:
COMPLETED
A Combination Therapy In Patients With Social Anxiety Disorder
Lead Sponsor:
GlaxoSmithKline
Conditions:
Social Phobia
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of Vestipitant and Paroxetine in patients with Social Anxiety Disorder (SAD)
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Primary diagnosis of Generalised Social Anxiety Disorder as defined in DSM-IV.
- Capable of giving informed consent and willing to comply with the study requirements.
- Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control.
- Exclusion criteria:
- Primary diagnosis within the past 6 months of another Axis 1 disorder such as Major Depression or another anxiety disorder.
- Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
- Subjects who, in the investigator's judgement pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
- Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
- Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00403962
Start Date
November 1 2004
End Date
August 1 2005
Last Update
September 15 2016
Active Locations (17)
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1
GSK Investigational Site
Hilleroed, Denmark, 3400
2
GSK Investigational Site
Hvidovre, Denmark, 2650
3
GSK Investigational Site
Koebenhavn K, Denmark, 1256
4
GSK Investigational Site
Koebenhavn OE, Denmark, 2100