Clinical trial

Quetiapine Fumarate Bipolar Maintenance Monotherapy

NCT00314184 · AstraZeneca, Industry · Completed

Key facts

NCT number NCT00314184
Title Quetiapine Fumarate Bipolar Maintenance Monotherapy
Official title 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
Acronym SPaRCLe
Lead sponsor AstraZeneca, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Bipolar Disorder
Intervention type Drug
Interventions quetiapine fumarate
Enrollment 1,255
Start date Mar 1, 2005
Completion Jul 1, 2007
First posted Apr 13, 2006
Last update posted Dec 22, 2008
Countries Argentina, Bulgaria, Colombia, India, Lithuania, Malaysia, Mexico, Peru, Philippines, Romania, Russia, Taiwan and 3 more

At a glance

  • 10–99 Study sites
  • No Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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