Long-Term Study Of Paroxetine in Women and Men
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Phobic Disorders
Intervention: BRL29060A (Drug); paroxetine hydrochloride hydrate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)
Clinical Details
Official title: Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-Term Study-
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)
Secondary outcome: Proportion of patients responding with a CGI Global Improvement Item.
Change from baseline in the CGI Severity of Illness score.
Change from baseline in the HAM-D total score.
Proportion of patients continuing treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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.
- 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 24 weeks 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.
Locations and Contacts
GSK Clinical Trials Call Center, Tokyo 144, Japan
GSK Clinical Trials Call Center, Tokyo 184, Japan
GSK Clinical Trials Call Center, Tokyo 107, Japan
GSK Clinical Trials Call Center, Tokyo 194, Japan
GSK Clinical Trials Call Center, Tokyo 164, Japan
GSK Clinical Trials Call Center, Tokyo 154, Japan
GSK Clinical Trials Call Center, Yokohama-city 220, Japan
GSK Clinical Trials Call Center, Saitama-city 330, Japan
GSK Clinical Trials Call Center, Kawaguchi-city 332, Japan
GSK Clinical Trials Call Center, Tokyo 108, Japan
Additional Information
Starting date: July 2005
Last updated: June 28, 2007
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