Study of Quetiapine Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomanic Symptoms or Mild Manic Symptoms

Phase 3 Completed 40 enrolled Lindner Center of HOPE AstraZeneca · collab University of Cincinnati · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this research study is to evaluate the safety, tolerability, and efficacy of quetiapine compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Quetiapine is approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania.

Timeline

Start: 2004-02
Primary completion: 2007-12
Completion: 2007-12

Publications

McElroy SL, Martens BE, Winstanley EL, Creech R, Malhotra S, Keck PE Jr. Placebo-controlled study of quetiapine monotherapy in ambulatory bipolar spectrum disorder with moderate-to-severe hypomania or mild mania. J Affect Disord. 2010 Jul;124(1-2):157-63. doi: 10.1016/j.jad.2009.11.014. Epub 2009 Dec 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quetiapine	Small molecule	50 mg	Oral
Subject	Quetiapine	Small molecule	800 mg	Oral

Study of Quetiapine Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomanic Symptoms or Mild Manic Symptoms

Summary

Timeline

Publications

Drugs

Indications