Last updated: 11/07/2018 19:37:57

A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder

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GSK study ID
TMT106386
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Clinicaltrials.gov ID
NCT00470483
EudraCT ID
2006-000233-36
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, Randomized, Placebo-Controlled, Parallel Group, fMRI and PET Study Comparing Emotional Challenge-induced Regional Cerebral Blood Flow Changes Before and After 8 Weeks of Treatment With Placebo and Paroxetine in Subjects with Social Anxiety Disorder
Trial description: To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

fMRI BOLD response in the amygdala and insula elicited by the Matching Emotional Face paradigm at baseline and after 8 weeks of treatment. State-anxiety inventory (STAI-S) after the Public Speaking challenge (only patients).

Timeframe: baseline and after 8 weeks

Secondary outcomes:

fMRI BOLD response in selected neuroanatomical ROI elicited by the by Resting State and by other exploratory paradigms at baseline (all subjects) and after 8 weeks of treatment with paroxetine compared to placebo (only patients).

Timeframe: baseline and after 8 weeks

Interventions:
  • Drug: Placebo treatment during 8 weeks
  • Drug: Paroxetine treatment during 8 weeks
    • Enrollment:
    56
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Mónica Giménez, Hector Ortiz, Carles Soriano-Mas, Marina López-Solà, Magí Farré, Joan Deus, Rocio Martín-Santos, Sofia Fernandes, Paolo Fina, Massimo Bani, Stefano Zancan, Jesús Pujol, Emilio Merlo-Pich, . Functional effects of chronic paroxetine versus placebo on the fear, stress and anxiety neurocircuitry in Social Anxiety Disorder: Initial validtion of an imaging protocol for drug discovery. Eur Neuropsychopharmacol. 2014;24(1):105-116.
    Medical condition
    Social Phobia
    Product
    paroxetine
    Collaborators
    Not applicable
    Study date(s)
    January 2007 to January 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Outpatient with Social Anxiety Disorder
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Outpatient with Social Anxiety Disorder
    • The subject is healthy
    • Willing to restrict alcohol intake
    • Capable of giving informed consent Exclusion criteria:
    • Subjects with depression or any other psychiatric condition
    • Subjects positive for HIV or hepatitis
    • Subjects taking drugs or other medication
    • Pregnant or becoming pregnant during the study
    • Subjects who have donated blood
    • Subjects who are left-handed
    • Subjects with claustrophobia
    • Subjects with an electronic device or ferromagnetic metal foreign body

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Barcelona, Spain, E-08003
    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
    2009-07-01

    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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    Additional information
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