A Combination Therapy In Patients With Social Anxiety Disorder
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Social Anxiety Disorder
Intervention: vestipitant/paroxetine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, MD, PhD, Study Director, Affiliation: GlaxoSmithKline
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)
Clinical Details
Official title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Comparing the Efficacy and Safety of GW597599/Paroxetine Combination or Paroxetine Monotherapy to Placebo in Patients With Social Anxiety Disorder (SAD)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Change in score on a Social Anxiety Disorder rating scale following 12 weeks of treatment.
Secondary outcome: Change in score on a number of rating scales following 12 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
GSK Investigational Site, Hilleroed 3400, Denmark
GSK Investigational Site, Hvidovre 2650, Denmark
GSK Investigational Site, Koebenhavn K 1256, Denmark
GSK Investigational Site, Koebenhavn OE 2100, Denmark
GSK Investigational Site, Risskov 8240, Denmark
GSK Investigational Site, Skanderborg 8660, Denmark
GSK Investigational Site, Soroe 4180, Denmark
GSK Investigational Site, Berlin 10629, Germany
GSK Investigational Site, Berlin 13053, Germany
GSK Investigational Site, Bergen N-5068, Norway
GSK Investigational Site, Hamar N-2317, Norway
GSK Investigational Site, Oslo 0364, Norway
GSK Investigational Site, Sandvika 1338, Norway
GSK Investigational Site, Bloemfontein, South Africa
GSK Investigational Site, Tygerberg 7505, South Africa
GSK Investigational Site, Huettenberg, Hessen 35625, Germany
GSK Investigational Site, Achim, Niedersachsen 28832, Germany
Additional Information
Starting date: November 2004
Last updated: October 15, 2008
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