Bipolar CHOICE (clinical health outcomes initiative in comparative effectiveness)

A pragmatic 6-month trial of lithium versus quetiapine for Bipolar disorder

Andrew A. Nierenberg, Susan L. McElroy, Edward S. Friedman, Terence A. Ketter, Richard C. Shelton, Thilo Deckersbach, Melvin G. McInnis, Charles L. Bowden, Mauricio Tohen, James H. Kocsis, Joseph R. Calabrese, Gustavo Kinrys, William V. Bobo, Vivek Singh, Masoud Kamali, David Kemp, Benjamin Brody, Noreen A. Reilly-Harrington, Louisa G. Sylvia, Leah W. Shesler & 6 others Emily E. Bernstein, David Schoenfeld, Dustin J. Rabideau, Andrew C. Leon, Stephen Faraone, Michael E. Thase

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)90-99
Number of pages10
JournalJournal of Clinical Psychiatry
Volume77
Issue number1
DOIs
StatePublished - Jan 1 2016
Externally publishedYes

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Bipolar Disorder
Lithium
Health
Social Adjustment
Antipsychotic Agents
Quetiapine Fumarate
Suicidal Ideation
Diagnostic and Statistical Manual of Mental Disorders
Anxiety
Quality of Life
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Psychiatry and Mental health

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Bipolar CHOICE (clinical health outcomes initiative in comparative effectiveness) : A pragmatic 6-month trial of lithium versus quetiapine for Bipolar disorder. / Nierenberg, Andrew A.; McElroy, Susan L.; Friedman, Edward S.; Ketter, Terence A.; Shelton, Richard C.; Deckersbach, Thilo; McInnis, Melvin G.; Bowden, Charles L.; Tohen, Mauricio; Kocsis, James H.; Calabrese, Joseph R.; Kinrys, Gustavo; Bobo, William V.; Singh, Vivek; Kamali, Masoud; Kemp, David; Brody, Benjamin; Reilly-Harrington, Noreen A.; Sylvia, Louisa G.; Shesler, Leah W.; Bernstein, Emily E.; Schoenfeld, David; Rabideau, Dustin J.; Leon, Andrew C.; Faraone, Stephen; Thase, Michael E.

In: Journal of Clinical Psychiatry, Vol. 77, No. 1, 01.01.2016, p. 90-99.

Research output: Contribution to journalArticle

Nierenberg, AA, McElroy, SL, Friedman, ES, Ketter, TA, Shelton, RC, Deckersbach, T, McInnis, MG, Bowden, CL, Tohen, M, Kocsis, JH, Calabrese, JR, Kinrys, G, Bobo, WV, Singh, V, Kamali, M, Kemp, D, Brody, B, Reilly-Harrington, NA, Sylvia, LG, Shesler, LW, Bernstein, EE, Schoenfeld, D, Rabideau, DJ, Leon, AC, Faraone, S & Thase, ME 2016, 'Bipolar CHOICE (clinical health outcomes initiative in comparative effectiveness): A pragmatic 6-month trial of lithium versus quetiapine for Bipolar disorder', Journal of Clinical Psychiatry, vol. 77, no. 1, pp. 90-99. https://doi.org/10.4088/JCP.14m09349
Nierenberg, Andrew A. ; McElroy, Susan L. ; Friedman, Edward S. ; Ketter, Terence A. ; Shelton, Richard C. ; Deckersbach, Thilo ; McInnis, Melvin G. ; Bowden, Charles L. ; Tohen, Mauricio ; Kocsis, James H. ; Calabrese, Joseph R. ; Kinrys, Gustavo ; Bobo, William V. ; Singh, Vivek ; Kamali, Masoud ; Kemp, David ; Brody, Benjamin ; Reilly-Harrington, Noreen A. ; Sylvia, Louisa G. ; Shesler, Leah W. ; Bernstein, Emily E. ; Schoenfeld, David ; Rabideau, Dustin J. ; Leon, Andrew C. ; Faraone, Stephen ; Thase, Michael E. / Bipolar CHOICE (clinical health outcomes initiative in comparative effectiveness) : A pragmatic 6-month trial of lithium versus quetiapine for Bipolar disorder. In: Journal of Clinical Psychiatry. 2016 ; Vol. 77, No. 1. pp. 90-99.
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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 - 2016/1/1

Y1 - 2016/1/1

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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