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Completed

NCT Number: NCT00264654

Long-term Study Of Paroxetine in Women and Men

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

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Key information

Conditions

Social Phobia Anxiety Disorders Disease Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Phobia, Social Phobic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Saitama, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BRL29060A

Drug

paroxetine hydrochloride hydrate

Drug

Other names: BRL29060A

Primary outcomes

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

    Time frame: 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.

    Time frame: 52 Weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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>

Acronym: SAD

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Dec 13, 2005
Registry last updated
Apr 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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