Comparative Effectiveness Study for Bipolar Disorder

Completed · Phase 4

Conditions studied: Bipolar Disorder

In brief

The purpose of this study is to compare the effectiveness of lithium and quetiapine for the treatment of individuals with bipolar disorder.

Key facts

Study ID

NCT01331304

Run by

Massachusetts General Hospital

People needed

482

Starts

2010-09-01

Expected to finish

2013-09-01

Last updated by the study team

2018-04-26

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets DSM-IV criteria for BD I or II, which is the primary focus of treatment
• Able to give written informed consent
• Age > to 18 years and < 68 years
• Women of child bearing potential must agree to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence from intercourse; Depo Provera is acceptable if it is started 3 months prior to enrollment), inform their doctor at the earliest possible time of their plans to conceive, and to understand the risks of lithium and other study treatments to the fetus and infant
• Currently symptomatic, as defined as a Clinical Global Impression - Bipolar Disorder Overall Severity (CGI-BP-S) score of at least 3 (mild)
• If currently taking an SGA, participants would be required to be willing to either discontinue or switch to QTP
• Willing to be randomized to either QTP+APT or Li+APT.

You may not qualify if…

• Unwilling or unable to comply with study requirements
• If maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1
• Patients who have had intolerable side effects with QTP or Li
• Patients whose clinical status requires inpatient care
• Drug/alcohol dependence within the past 30 days
• Pregnancy as determined by urine pregnancy test or breastfeeding
• History of nonresponse to Li at a serum level of ≥ 1.0 mEq/L ≥ 8 weeks
• History of nonresponse to QTP at doses of at least 600 mg ≥ 8 weeks.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University School of Medicine — Stanford, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Weill Cornell Medical College — New York, New York, United States
• Case Western Reserve University School of Medicine — Cleveland, Ohio, United States
• The Lindner Center of HOPE — Mason, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• The University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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