A Combination Therapy In Patients With Social Anxiety Disorder

September 13, 2016 updated by: GlaxoSmithKline

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hilleroed, Denmark, 3400
        • GSK Investigational Site
      • Hvidovre, Denmark, 2650
        • GSK Investigational Site
      • Koebenhavn K, Denmark, 1256
        • GSK Investigational Site
      • Koebenhavn OE, Denmark, 2100
        • GSK Investigational Site
      • Risskov, Denmark, 8240
        • GSK Investigational Site
      • Skanderborg, Denmark, 8660
        • GSK Investigational Site
      • Soroe, Denmark, 4180
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10629
        • GSK Investigational Site
      • Berlin, Germany, 13053
        • GSK Investigational Site
    • Hessen
      • Huettenberg, Hessen, Germany, 35625
        • GSK Investigational Site
    • Niedersachsen
      • Achim, Niedersachsen, Germany, 28832
        • GSK Investigational Site
  • Norway
      • Bergen, Norway, N-5068
        • GSK Investigational Site
      • Hamar, Norway, N-2317
        • GSK Investigational Site
      • Oslo, Norway, 0364
        • GSK Investigational Site
      • Sandvika, Norway, 1338
        • GSK Investigational Site
  • South Africa
      • Bloemfontein, South Africa
        • GSK Investigational Site
      • Tygerberg, South Africa, 7505
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

November 23, 2006

First Posted (Estimate)

November 27, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKP103401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Clinical Study Report
    Information identifier: NKP103401
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: NKP103401
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: NKP103401
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: NKP103401
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: NKP103401
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: NKP103401
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: NKP103401
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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