TY - JOUR
T1 - Bipolar CHOICE (clinical health outcomes initiative in comparative effectiveness)
T2 - A pragmatic 6-month trial of lithium versus quetiapine for Bipolar disorder
AU - Nierenberg, Andrew A.
AU - McElroy, Susan L.
AU - Friedman, Edward S.
AU - Ketter, Terence A.
AU - Shelton, Richard C.
AU - Deckersbach, Thilo
AU - McInnis, Melvin G.
AU - Bowden, Charles L.
AU - Tohen, Mauricio
AU - Kocsis, James H.
AU - Calabrese, Joseph R.
AU - Kinrys, Gustavo
AU - Bobo, William V.
AU - Singh, Vivek
AU - Kamali, Masoud
AU - Kemp, David
AU - Brody, Benjamin
AU - Reilly-Harrington, Noreen A.
AU - Sylvia, Louisa G.
AU - Shesler, Leah W.
AU - Bernstein, Emily E.
AU - Schoenfeld, David
AU - Rabideau, Dustin J.
AU - Leon, Andrew C.
AU - Faraone, Stephen
AU - Thase, Michael E.
N1 - Funding Information:
The authors acknowledge the members of the Bipolar CHOICE Study Group who contributed significantly to this research study (in alphabetical order by last name): Claudia Baldassano, MD; Leah Casuto, MD; Cheryl McCullumsmith, MD; Timothy Denko, MD; Astrid Desrosiers, MD; Jamie Dupuy, MD; Rachel Fargason, MD; Keming Gao, MD; John Hawkins, MD; Chang-Gyu Hahn, MD, PhD; Adrian Lagakos; Li Li, MD; Falk Lohoff, MD; Jules Martowski, BA; Cheryl McCullumsmith, MD; Stephanie McMurrich, PhD; Nicole Mori, RN; Leah Pickett, NP; Brian Pollock, RN; Marlon Quinones, MD; Karl Rickels, MD; Martha Schinagle, MD; Amy Shui, MA; Duane Spiker, MD; Peter Thompson, MD; Po Wang, MD; Curtis Wittmann, MD; Sudeep Xavier, MD; Rusheng Zhang, MD. They also acknowledge the participants of the Bipolar CHOICE Stakeholder Summit held on September 20, 2013, who provided crucial feedback about the project (in alphabetical order by last name): William Beecroft, MD (Medical Director for Behavioral Health Services at Blue Care Network, Blue Cross Blue Shield of Michigan), Allen Doederlein, BA (President, Depression and Bipolar Support Alliance; DBSA), Kenneth Duckworth, MD (Medical Director, National Alliance on Mental Illness; NAMI), Deborah Friedman (Executive Director, Jewish Residential Services), Lucinda Jewell, EdM (Board Chair, Depression and Bipolar Support Alliance; DBSA), Kimberly Lenz, PharmD (Clinical Pharmacy Manager, Mass Health Insurance), Kathy Sanders, MD (Deputy Commissioner, Department of Mental Health in Massachusetts), Jeffrey Simmons, MD (Medical Director for Behavioral Health, Blue Cross Blue Shield of Massachusetts), Scott Suckow (Executive Director, International Bipolar Foundation), Julie Totten, MBA (Executive Director, Families for Depression Awareness), Hyong Un, MD (Head of EAP & Chief Psychiatric Officer, Aetna Ohio), and Susan Weinstein, JD (Director of Programs and Marketing, Families for Depression Awareness).
Publisher Copyright:
© Copyright 2016 Physicians Postgraduate Press, Inc.
PY - 2016/1
Y1 - 2016/1
N2 - Background: Bipolar disorder is among the 10 most disabling medical conditions worldwide. While lithium has been used extensively for bipolar disorder since the 1970s, second-generation antipsychotics (SGAs) have supplanted lithium since 1998. To date, no randomized comparative-effectiveness study has compared lithium and any SGA. Method: Within the duration of the study (September 2010-September 2013), participants with bipolar I or II disorder (DSM-IV-TR) were randomized for 6 months to receive lithium (n = 240) or quetiapine (n = 242). Lithium and quetiapine were combined with other medications for bipolar disorder consistent with typical clinical practice (adjunctive personalized treatment [APT], excluding any SGA for the lithium + APT group and excluding lithium or any other SGA for the quetiapine + APT group). Coprimary outcome measures included Clinical Global Impressions-Efficacy Index (CGI-EI) and necessary clinical adjustments, which measured number of changes in adjunctive personalized treatment. Secondary measures included a full range of symptoms, cardiovascular risk, functioning, quality of life, suicidal ideation and behavior, and adverse events. Results: Participants improved across all measures, and over 20% had a sustained response. Primary (CGI-EI, P =.59; necessary clinical adjustments, P =.15) and secondary outcome changes were not statistically significantly different between the 2 groups. For participants with greater manic/hypomanic symptoms, CGI-EI changes were significantly more favorable with quetiapine + APT (P =.02). Among those with anxiety, the lithium + APT group had fewer necessary clinical adjustments per month (P =.02). Lithium was better tolerated than quetiapine in terms of the burden of side effects frequency (P =.05), intensity (P =.01), and impairment (P =.01). Conclusions: Despite adequate power to detect clinically meaningful differences, we found outcomes with lithium + APT and quetiapine + APT were not significantly different across 6 months of treatment for bipolar disorder.
AB - Background: Bipolar disorder is among the 10 most disabling medical conditions worldwide. While lithium has been used extensively for bipolar disorder since the 1970s, second-generation antipsychotics (SGAs) have supplanted lithium since 1998. To date, no randomized comparative-effectiveness study has compared lithium and any SGA. Method: Within the duration of the study (September 2010-September 2013), participants with bipolar I or II disorder (DSM-IV-TR) were randomized for 6 months to receive lithium (n = 240) or quetiapine (n = 242). Lithium and quetiapine were combined with other medications for bipolar disorder consistent with typical clinical practice (adjunctive personalized treatment [APT], excluding any SGA for the lithium + APT group and excluding lithium or any other SGA for the quetiapine + APT group). Coprimary outcome measures included Clinical Global Impressions-Efficacy Index (CGI-EI) and necessary clinical adjustments, which measured number of changes in adjunctive personalized treatment. Secondary measures included a full range of symptoms, cardiovascular risk, functioning, quality of life, suicidal ideation and behavior, and adverse events. Results: Participants improved across all measures, and over 20% had a sustained response. Primary (CGI-EI, P =.59; necessary clinical adjustments, P =.15) and secondary outcome changes were not statistically significantly different between the 2 groups. For participants with greater manic/hypomanic symptoms, CGI-EI changes were significantly more favorable with quetiapine + APT (P =.02). Among those with anxiety, the lithium + APT group had fewer necessary clinical adjustments per month (P =.02). Lithium was better tolerated than quetiapine in terms of the burden of side effects frequency (P =.05), intensity (P =.01), and impairment (P =.01). Conclusions: Despite adequate power to detect clinically meaningful differences, we found outcomes with lithium + APT and quetiapine + APT were not significantly different across 6 months of treatment for bipolar disorder.
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U2 - 10.4088/JCP.14m09349
DO - 10.4088/JCP.14m09349
M3 - Article
C2 - 26845264
AN - SCOPUS:84957803695
VL - 77
SP - 90
EP - 99
JO - Diseases of the Nervous System
JF - Diseases of the Nervous System
SN - 0160-6689
IS - 1
ER -