Long-term Study Of Paroxetine in Women and Men
SAD
Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-term Study- <Phase III Study>
1 other identifier
interventional
50
1 country
2
Brief Summary
This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2005
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 9, 2005
CompletedFirst Posted
Study publicly available on registry
December 13, 2005
CompletedApril 15, 2013
May 1, 2012
1 month
December 9, 2005
April 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)
52 Weeks
Secondary Outcomes (1)
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.
52 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (3)
GSK Investigational Site
Saitama, 332-0012, Japan
GSK Investigational Site
Tokyo, 194-0022, Japan
GSK Investigational Site
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2005
First Posted
December 13, 2005
Study Start
October 1, 2005
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
April 15, 2013
Record last verified: 2012-05