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Long-term Study Of Paroxetine in Women and Men (SAD)

Primary Purpose

Social Phobia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BRL29060A
paroxetine hydrochloride hydrate
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia focused on measuring Social, (SAD), Anxiety, Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)

Secondary Outcome Measures

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.

Full Information

First Posted
December 9, 2005
Last Updated
April 11, 2013
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00264654
Brief Title
Long-term Study Of Paroxetine in Women and Men
Acronym
SAD
Official Title
Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-term Study- <Phase III Study>
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
Social, (SAD), Anxiety, Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BRL29060A
Intervention Type
Drug
Intervention Name(s)
paroxetine hydrochloride hydrate
Other Intervention Name(s)
BRL29060A
Primary Outcome Measure Information:
Title
Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
332-0012
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
194-0022
Country
Japan
Facility Name
GSK Investigational Site

12. IPD Sharing Statement

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Long-term Study Of Paroxetine in Women and Men

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