A Combination Therapy In Patients With Social Anxiety Disorder

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00403962

Enrollment

204

Registered

2006-11-27

Start date

2004-11-30

Completion date

2005-08-31

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Phobia

Keywords

anxiety, Social Anxiety Disorder, SAD

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)

Interventions

DRUGvestipitant/paroxetine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
Change in score on a Social Anxiety Disorder rating scale following 12 weeks of treatment.	—

Secondary

Measure	Time frame
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.	—

Countries

Denmark, Germany, Norway, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026