Last updated: 11/04/2018 09:43:22

PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety Patients

Request patient level data
GSK study ID
NKP102280
See study documents
Clinicaltrials.gov ID
NCT00343707
EudraCT ID
2004-001481-40
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 double-blind, triple dummy, placebo-controlled, randomised, parallel group positron emission tomography study to investigate the effects of a 8 week administration of GW597599 and paroxetine either alone or in combination on regional cerebral blood flow during a public speaking test in subjects affected by social phobia.
Trial description: This six-arm study is being conducted to measure the effect of a combination of paroxetine and vestipitant on the arousal induced by public speaking in Seasonal Effective Disorder (SAD) patients, using functional brain imaging readouts (i.e., WAT(Wave Analysis Technology) PET(Positron Emission Tomography)), after one or eight weeks of treatment. The effect of paroxetine alone after one or eight weeks of treatment will also be measured.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment.

Timeframe: N/A

Secondary outcomes:

To assess symptomatic and physiological measures of anxiety induced by the public speaking task and social anxiety symptoms during eight weeks of treatment. To evaluate safety, tolerability and the effect on sexual function of treatment.

Timeframe: N/A

Interventions:
  • Drug: vestipitant
  • Drug: paroxetine
    • Enrollment:
    72
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Depressive Disorder and Anxiety Disorders
    Product
    paroxetine
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to November 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Social phobic ambulatory subjects, defined according to DSM-IV criteria.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Social phobic ambulatory subjects, defined according to DSM-IV criteria.
    • Must be capable of giving informed consent and can comply with the study requirements.
    • Women of childbearing potential must agree to acceptable method of birth control. Exclusion criteria:
    • Primary diagnosis within the past 6 months of other psychiatric conditions 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) findings.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    UPPSALA, Sweden, SE-753 23
    Status
    Will Be Recruiting
    Contact us

    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
    2005-15-11

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website