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NCT00403962 Clinical Trial

A Combination Therapy In Patients With Social Anxiety Disorder

Social Phobia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00403962
Other study ID # NKP103401
Secondary ID
Status Completed
Phase Phase 2
First received August 29, 2005
Last updated September 13, 2016
Start date November 2004
Est. completion date August 2005

Study information
Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesSouth Africa: Medicines Control CouncilDenmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 204
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• vestipitant/paroxetine

Locations
Country Name City State
Denmark GSK Investigational Site Hilleroed
Denmark GSK Investigational Site Hvidovre
Denmark GSK Investigational Site Koebenhavn K
Denmark GSK Investigational Site Koebenhavn OE
Denmark GSK Investigational Site Risskov
Denmark GSK Investigational Site Skanderborg
Denmark GSK Investigational Site Soroe
Germany GSK Investigational Site Achim Niedersachsen
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Huettenberg Hessen
Norway GSK Investigational Site Bergen
Norway GSK Investigational Site Hamar
Norway GSK Investigational Site Oslo
Norway GSK Investigational Site Sandvika
South Africa GSK Investigational Site Bloemfontein
South Africa GSK Investigational Site Tygerberg

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  Germany,  Norway,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in score on a Social Anxiety Disorder rating scale following 12 weeks of treatment.
Secondary 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.
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