A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy and Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients
Phase of Trial: Phase III
Latest Information Update: 01 Nov 2013
At a glance
- Drugs Quetiapine (Primary)
- Indications Bipolar I disorders
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors AstraZeneca
- 01 Aug 2008 Results published in Journal of Affective Disorders.
- 14 May 2008 FDA approval for use of quetiapine for the maintenance treatment of patients with bipolar I disorders, as adjunct to lithium or valproate semisodium, based on this and another phase III trial.
- 10 Jan 2008 Status change from in progress to completed.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History