DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Comparative Effectiveness Study for Bipolar Disorder

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Lithium (Drug); Quetiapine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Andrew A Nierenberg, MD, Principal Investigator, Affiliation: Massachusetts General Hospital


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

Clinical Details

Official title: Comparative Effectiveness of a Second Generation Antipsychotic Mood Stabilizer And a Classic Mood Stabilizer for Bipolar Disorder

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Clinical Global Impression-Efficacy Index (CGI-EI)

Necessary Clinical Adjustments

Secondary outcome:

Risk of Cardiovascular Disease - Framingham Risk Score

Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)

Detailed description: Mood stabilizers, medications that prevent future mood episodes, are the foundation for treatment of bipolar disorder. While all published bipolar disorder treatment guidelines recommend that pharmacotherapy should include mood stabilizers for long-term maintenance treatment, no randomized comparative effectiveness studies have examined the real-world advantages and disadvantages of the newer second generation antipsychotic (SGA) mood stabilizers compared to the classic mood stabilizers, such as lithium (Li). No studies have looked at the effectiveness of SGAs compared to mood stabilizers when used in the context of other medications required to manage bipolar patients, since bipolar disorder patients take a median of 3 medications for optimal outcomes. Quetiapine (QTP) is the most extensively studied, broadly efficacious and the most widely prescribed SGA for bipolar disorder. The classic mood stabilizer Li has the largest evidence base for treating bipolar disorder, but has been largely supplanted by the SGAs. Thus, this study compares symptomatic benefits and adverse effect burden between a QTP foundation with adjunctive personalized treatments (QTP+APT) and a mood stabilizer foundation consisting of Li with APT (Li+APT). APT will include any other medication needed with the following exceptions: the QTP+APT cannot receive Li and the Li+APT group cannot receive an antipsychotic. If, however, participants clinically require a switch to, or the addition of any other SGA or mood stabilizer, then those medications can be added as a rescue strategy that will be carefully recorded. Consistent with an effectiveness trial, participants will be able to continue in the study if they require a rescue treatment. The specific plan is a randomized, open, two arm, comparative effectiveness study of QTP+APT vs. Li+APT treatment for 6 months across 10 sites. In summary, this comparative effectiveness study compares fundamentally different acute and continuation treatments for bipolar disorder. The investigators address the key question of whether to use a prototypical mood stabilizing SGA (i. e., QTP) or the classical mood stabilizer Li as the foundational treatment in the context of other necessary adjunctive personalized treatments (APT).


Minimum age: 18 Years. Maximum age: 68 Years. Gender(s): Both.


Inclusion Criteria: 1. Meets DSM-IV criteria for BD I or II, which is the primary focus of treatment 2. Able to give written informed consent 3. Age > to 18 years and < 68 years 4. 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

5. Currently symptomatic, as defined as a Clinical Global Impression - Bipolar Disorder

Overall Severity (CGI-BP-S) score of at least 3 (mild) 6. If currently taking an SGA, participants would be required to be willing to either discontinue or switch to QTP 7. Willing to be randomized to either QTP+APT or Li+APT. Exclusion Criteria: 1. Unwilling or unable to comply with study requirements 2. If maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1 3. Patients who have had intolerable side effects with QTP or Li 4. Patients whose clinical status requires inpatient care 5. Drug/alcohol dependence within the past 30 days 6. Pregnancy as determined by urine pregnancy test or breastfeeding 7. History of nonresponse to Li at a serum level of ≥ 1. 0 mEq/L ≥ 8 weeks 8. History of nonresponse to QTP at doses of at least 600 mg ≥ 8 weeks.

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35205, United States

Stanford University School of Medicine, Stanford, California 94305, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

University of Michigan, Ann Arbor, Michigan 48109, United States

Weill Cornell Medical College, New York, New York 10065, United States

Case Western Reserve University School of Medicine, Cleveland, Ohio 44106, United States

The Lindner Center of HOPE, Mason, Ohio 45040, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

Vanderbilt University, Nashville, Tennessee 37212, United States

The University of Texas Health Science Center, San Antonio, Texas 78229, United States

Additional Information

Starting date: September 2010
Last updated: May 23, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017