Multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 3 study of the efficacy and safety of quetiapine fumarate and lithium as monotherapy for up to 104 weeks maintenance treatment of bipolar I disorder in adult patients
Phase of Trial: Phase III
Latest Information Update: 24 Apr 2014
At a glance
- Drugs Quetiapine (Primary) ; Lithium
- Indications Bipolar I disorders
- Focus Registrational; Therapeutic Use
- Acronyms SPaRCLe
- Sponsors AstraZeneca
- 12 Jul 2011 New source identified and integrated (European Clinical Trials Database)
- 12 Jul 2011 Planned end date 22 Jun 2008 added as reported by EudraCT.
- 01 Apr 2008 Primary endpoint 'Time to disease recurrence' has been met.