NCT00135525

Study Of Generalized Anxiety Disorder

Clinical Evaluation of BRL29060 A in Generalized Anxiety Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety in Generalized Anxiety Disorder patients

Detailed description

This study was a multi-center, randomized, placebo-controlled, double-blinded (placebo run-in will be single-blinded), group comparison study. Paroxetine 20mg/day (achieved via the starting dose of 10 mg/day for the first week) once daily, or placebo was orally administered once daily for 8 weeks (fixed dose was adopted in the Treatment phase) in patients with GAD. For subjects who were classed as non-responders at Week 8, paroxetine at 30 to 40mg/day (once daily) or placebo (once daily) was orally administered with flexible titration regimen for 4 weeks (fixed dose was adopted in the Treatment phase). The subjects underwent a taper phase in case they received Paroxetine 40mg/day, paroxetine 30mg/day or placebo at treatment completion or study withdrawal. A follow-up examination was conducted after 1 to 5 weeks from the last dose of the investigational product. The overall study duration requiring subject participation was 10 to 20 weeks.

Conditions

• Anxiety Disorder
• Anxiety Disorders

Interventions

Type	Name	Description
DRUG	Paroxetine	Fixed Dose (20 mg/day): The fixed dose of 20 mg/day was selected, because it is the recommended dose for the treatment of GAD in the US and other countries. Flexible Dose (20 - 40 mg/day): Overseas, the maximum dose in the treatment of GAD is 50 mg/day. However, 40 mg/day was selected as the maximum dose for this flexible dose session, because overseas clinical studies have indicated that paroxetine is sufficiently effective at doses of 20 - 40 mg/day and this is the dose range approved for depression/depressive episodes in Japan.
DRUG	Placebo	Placebo

Timeline

• Start date: 2003-05-01
• Primary completion: 2005-10-01
• Completion: 2006-05-01
• First posted: 2005-08-26
• Last updated: 2011-01-31