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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00264654
First received: December 9, 2005
Last updated: April 11, 2013
Last verified: May 2012

December 9, 2005
April 11, 2013
October 2005
November 2005   (final data collection date for primary outcome measure)
Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0) [ Time Frame: 52 Weeks ]
Change from baseline in the LSAS total score at week 52 (Score at week 52 - Score at week 0)
Complete list of historical versions of study NCT00264654 on ClinicalTrials.gov Archive Site
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 ]
  • - 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.
Not Provided
Not Provided
 
Long-term Study Of Paroxetine in Women and Men
Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-term Study- <Phase III Study>

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Social Phobia
  • Drug: BRL29060A
  • Drug: paroxetine hydrochloride hydrate
    Other Names:
    • BRL29060A
    • paroxetine hydrochloride hydrate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2005
November 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Spain
 
NCT00264654
PIR104777
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP