Trial intelligence / Profile preview

Vortioxetine Relapse Prevention in GAD

NCT00788034Phase 3

Key facts

Status: Completed
Start: Oct 2008
Primary completion: Jun 2010
Countries: 11
Sponsor: Lundbeck
Modality: Small Molecules

Drugs: vortioxetine
Conditions: generalized anxiety disorder (GAD)

Overview

Phase 3, randomised, double-blind trial in generalized anxiety disorder (GAD) comparing Lu AA21004 with Placebo (2 arms). Primary endpoint: Time to relapse at 24 weeks. Started Oct 2008; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Lu AA21004
Vortioxetine 5 or 10 mg/day
Placebo
Placebo once daily

Who it enrols

Patients with a primary diagnosis of GAD, HAM-A >= 20, and MADRS <= 16. Excludes other psychiatric disorders and substance abuse.

Endpoints

Primary

Time to relapse24 weeks

Secondary

Relapse rates24 weeks
Hamilton Anxiety Rating Scale24 weeks
Clinical Global Impression Scale24 weeks
Medical Outcomes Study Short Form-3624 weeks
Sheehan Disability Scale24 weeks

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