Last updated: 11/04/2018 09:43:44

A Combination Therapy In Patients With Social Anxiety Disorder

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GSK study ID
NKP103401
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Clinicaltrials.gov ID
NCT00403962
EudraCT ID
2004-001894-24
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: 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)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: vestipitant/paroxetine
    • Enrollment:
    204
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Social Phobia
    Product
    paroxetine, vestipitant
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to August 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Primary diagnosis of Generalised Social Anxiety Disorder as defined in DSM-IV.
    Inclusion and exclusion criteria
    Inclusion 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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bloemfontein, South Africa
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10629
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hvidovre, Denmark, 2650
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hilleroed, Denmark, 3400
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Koebenhavn K, Denmark, 1256
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Skanderborg, Denmark, 8660
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 17 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-30-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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