Last updated: 11/04/2018 10:15:01

Social Anxiety Disorder Study Of Paroxetine

GSK study ID
PIR104776
See study documents
Clinicaltrials.gov ID
NCT00318669
See results summary
EudraCT ID
Not applicable
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: Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) A Double-blind, Placebo-controlled Study
Trial description: This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in the LSAS total overall score at Week 12

Timeframe: Baseline (Week 0) and Week 12

Secondary outcomes:

Percentage of participants responding with a Clinical Global Impression (CGI) Global Improvement Item score at Week 12

Timeframe: Week 12

Change from Baseline in LSAS total score at Weeks 2, 3, 4, 6, 8 and 10

Timeframe: Baseline (Week 0) up to Week 10

Change from Baseline in LSAS Fear/Anxiety subscale score at Weeks 2, 3, 4, 6, 8, 10 and 12

Timeframe: Baseline (Week 0) up to Week 12

Change from Baseline in LSAS Avoidance subscale score at Weeks 2, 3, 4, 6, 8, 10 and 12

Timeframe: Baseline (Week 0) up to Week 12

Change from Baseline in CGI severity of illness score at Weeks 2, 3, 4, 6, 8, 10 and 12

Timeframe: Baseline (Week 0) up to Week 12

Change from Baseline in Hamilton Rating Scale for Depression (HAM-D) total score at Week 12

Timeframe: Baseline (Week 0) and Week 12

Percentage of participants continuing treatment

Timeframe: Up to Week 12

Interventions:
  • Drug: Paroxetine 20 mg
  • Drug: Paroxetine 40 mg
  • Drug: Placebo
    • Enrollment:
    399
    Primary completion date:
    2006-01-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Social Phobia
    Product
    paroxetine
    Collaborators
    Not applicable
    Study date(s)
    December 2005 to November 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria.
    • Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
    • Patients have a minimum score of 60 on the LSAS total score. Exclusion criteria:
    • Patients primarily diagnosed with a disorder that is categorized into Axis I excluding SAD by DSM-IV-TR (e.g. major depression, dysthymic disorder, specific phobia (simple phobia) , obsessive compulsive disorder, panic disorder) within 24weeks before week -2.
    • Patients with a history or complication of schizophrenia and bipolar disorder
    • Patients with a complication of body dysmorphic disorder.
    • Patients with evidence of substance abuse (alcohol or drugs)
    • substance dependence by DSM-IV-TR criteria within 24 weeks before week -2.
    • Patients who started psychotherapy and cognitive-behavioural therapy within 24 weeks before week-2, except for supportive psychotherapy.
    • Patients receiving electro-convulsive therapy (ECT) within 12 weeks before week -2.
    • Patients being pregnant, lactating or are of childbearing potential and are likely to become pregnant.
    • Patients with 3 or more points of HAM-D Item No. 3, or who are likely to attempt suicide.
    • Patients with a history or complication of cancer or malignant tumor.
    • Patients receiving MAO inhibitors (FP®) within 14 days before expected week 0 visit date.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Fukuoka, Japan, 810-0001
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Unknown, Japan
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 160-0023
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 107-0062
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 143-8541
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Unknown, Spain
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 18 Results

    Study documents

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-01-11
    Actual study completion date
    2006-01-11

    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

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website