|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00318669 |
|
Date of registration:
|
25/04/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Social Anxiety Disorder Study Of Paroxetine
|
|
Scientific title:
|
Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Double-blind, Placebo-controlled Study- |
|
Date of first enrolment:
|
December 2005 |
|
Target sample size:
|
390 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00318669 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
France
|
Japan
| | | | | | |
|
Contacts
|
|
Name:
|
GSK Clinical Trials |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
GlaxoSmithKline |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Phobic Disorders
|
|
Social Phobia
|
|
Intervention(s)
|
|
Drug: Paroxetine hydrochloride hydrate
|
|
Primary Outcome(s)
|
|
Change from baseline in the LSAS total score at week 12 (Score at week 12 - Score at week 0)
[Time Frame: 12 Weeks]
|
|
Secondary Outcome(s)
|
|
Proportion of patients responding with a CGI Global Improvement Item score. 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: 12 Weeks]
|
|
Secondary ID(s)
|
|
PIR104776
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|