A Combination Therapy In Patients With Social Anxiety Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-08-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Social Phobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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vestipitant/paroxetine

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hilleroed, , Denmark

Site Status

GSK Investigational Site

Hvidovre, , Denmark

Site Status

GSK Investigational Site

Koebenhavn K, , Denmark

Site Status

GSK Investigational Site

Koebenhavn OE, , Denmark

Site Status

GSK Investigational Site

Risskov, , Denmark

Site Status

GSK Investigational Site

Skanderborg, , Denmark

Site Status

GSK Investigational Site

Soroe, , Denmark

Site Status

GSK Investigational Site

Hüttenberg, Hesse, Germany

Site Status

GSK Investigational Site

Achim, Lower Saxony, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Bergen, , Norway

Site Status

GSK Investigational Site

Hamar, , Norway

Site Status

GSK Investigational Site

Oslo, , Norway

Site Status

GSK Investigational Site

Sandvika, , Norway

Site Status

GSK Investigational Site

Bloemfontein, , South Africa

Site Status

GSK Investigational Site

Tygerberg, , South Africa

Site Status

Countries

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Denmark Germany Norway South Africa

Study Documents

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