Clinical trial NCT00403962: A Combination Therapy In Patients With Social Anxiety Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Phobia
Keywords: anxiety
Social Anxiety Disorder
SAD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-27
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: Change in score on a Social Anxiety Disorder rating scale following 12 weeks of treatment.
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Hilleroed
country: Denmark
facility: GSK Investigational Site
city: Hvidovre
country: Denmark
facility: GSK Investigational Site
city: Koebenhavn K
country: Denmark
facility: GSK Investigational Site
city: Koebenhavn OE
country: Denmark
facility: GSK Investigational Site
city: Risskov
country: Denmark
facility: GSK Investigational Site
city: Skanderborg
country: Denmark
facility: GSK Investigational Site
city: Soroe
country: Denmark
facility: GSK Investigational Site
city: Huettenberg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Achim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Hamar
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Sandvika
country: Norway
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Tygerberg
country: South Africa
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: