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.
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 - Journal of Clinical Psychiatry
JF - Journal of Clinical Psychiatry
SN - 0160-6689
IS - 1
ER -