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

Volumn 77, Issue 1, 2016, Pages 90-99

  Nierenberg, Andrew A ^a,b   McElroy, Susan L ^c   Friedman, Edward S ^d   Ketter, Terence A ^e   Shelton, Richard C ^f   Deckersbach, Thilo ^a,b   McInnis, Melvin G ^g   Bowden, Charles L ^h   Tohen, Mauricio ⁱ   Kocsis, James H ^j   Calabrese, Joseph R ^k   Kinrys, Gustavo ^a,b   Bobo, William V ^l   Singh, Vivek ^h   Kamali, Masoud ^g   Kemp, David ^k   Brody, Benjamin ^j   Reilly Harrington, Noreen A ^a,b   Sylvia, Louisa G ^a,b   Shesler, Leah W ^a   Bernstein, Emily E ^a   Schoenfeld, David ^a   Rabideau, Dustin J ^a   Leon, Andrew C ^k   Faraone, Stephen ^m   Thase, Michael E ⁿ   more..

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^d UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^e STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^g UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^h UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

ⁱ UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER   (United States)

^j WEILL CORNELL MEDICAL COLLEGE   (United States)

^k CASE WESTERN RESERVE UNIVERSITY   (United States)

^l MAYO CLINIC   (United States)

^m SUNY UPSTATE MEDICAL UNIVERSITY   (United States)

ⁿ UNIVERSITY OF PENNSYLVANIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

LITHIUM; QUETIAPINE; NEUROLEPTIC AGENT;

ADULT; AGORAPHOBIA; ANXIETY; ARTICLE; BEHAVIOR; BIPOLAR I DISORDER; BIPOLAR II DISORDER; BIPOLAR INVENTORY OF SYMPTOMS SCALE; CARDIOVASCULAR RISK; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL PRACTICE; COLUMBIA SUICIDE SEVERITY RATING SCALE; COMORBIDITY; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DRUG TOLERABILITY; DSM-IV; FEMALE; FRAMINGHAM RISK SCORE; GENERALIZED ANXIETY DISORDER; HUMAN; HYPOMANIA; INFORMED CONSENT; INSTITUTIONAL REVIEW; MAJOR CLINICAL STUDY; MALE; MANIA; MONOTHERAPY; MONTGOMERY ASBERG DEPRESSION RATING SCALE; OUTCOME ASSESSMENT; PANIC; PARALLEL DESIGN; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RISK BENEFIT ANALYSIS; SOCIAL PHOBIA; SUICIDAL IDEATION; SYMPTOMATOLOGY; YOUNG MANIA RATING SCALE; BIPOLAR DISORDER; CLINICAL TRIAL; COMPARATIVE STUDY; MIDDLE AGED; MULTICENTER STUDY; TREATMENT OUTCOME;

ADULT; ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; FEMALE; HUMANS; LITHIUM; MALE; MIDDLE AGED; QUETIAPINE FUMARATE; TREATMENT OUTCOME;

EID: 84957803695     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.14m09349     Document Type: Article

References (41)

1. Merikangas KR, Akiskal HS, Angst J, et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry. 2007;64(5):543-552. doi:10.101/archpsyc.64.5.543 PubMed
2. Dilsaver SC. An estimate of the minimum economic burden of bipolar I and II disorders in the United States: 2009. J Affect Disord. 2011;129(1-3):79-83. doi:10.1016/j.jad.2010.08.030 PubMed
3. Judd LL, Schettler PJ, Akiskal HS, et al. Residual symptom recovery from major affective episodes in bipolar disorders and rapid episode relapse/recurrence. Arch Gen Psychiatry. 2008;65(4):386-394. doi:10.101/archpsyc.65.4.386 PubMed
4. Leboyer M, Soreca I, Scott J, et al. Can bipolar disorder be viewed as a multi-system inflammatory disease? J Affect Disord. 2012;141(1):1-10. doi:10.1016/j.jad.201.12.049 PubMed
5. Yatham LN, Kennedy SH, Parikh SV, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013. Bipolar Disord. 2013;15(1):1-44. doi:10.1/bdi.12025 PubMed
6. Malhi GS, Tanious M, Das P, et al. The science and practice of lithium therapy. Aust N Z J Psychiatry. 2012;46(3):192-211. doi:10.17/04867412437346 PubMed
7. Calabrese JR, Keck PE Jr, Macfadden W, et al. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry. 2005;162(7):1351-1360. doi:10.176/api.ajp. 162.7.1351 PubMed
8. Hayes J, Prah P, Nazareth I, et al. Prescribing trends in bipolar disorder: cohort study in the United Kingdom THIN primary care database 1995-2009. PLoS ONE. 2011;6(12):e28725. doi:10.1371/journal.pone.028725 PubMed
9. Vieta E, Suppes T, Eggens I, et al. Efficacy and safety of quetiapine in combination with lithium or divalproex for maintenance of patients with bipolar I disorder (international trial 126). J Affect Disord. 2008;109(3):251-263. doi:10.1016/j.jad.208.06.01 PubMed
10. Sheehan DV, McElroy SL, Harnett-Sheehan K, et al. Randomized, placebo-controlled trial of risperidone for acute treatment of bipolar anxiety. J Affect Disord. 2009;115(3):376-385. doi:10.1016/j.jad.208.10.05 PubMed
11. Ray WA, Chung CP, Murray KT, et al. Atypical antipsychotic drugs and the risk of sudden cardiac death. N Engl J Med. 2009;360(3):225-235. doi:10.1056/NEJMoa080694 PubMed
12. Pillarella J, Higashi A, Alexander GC, et al. Trends in use of second-generation antipsychotics for treatment of bipolar disorder in the United States, 1998-2009. Psychiatr Serv. 2012;63(1):83-86. doi:10.176/api.ps.201092 PubMed
13. Weisler RH, Nolen WA, Neijber A, et al; Trial 144 Study Investigators. Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study). J Clin Psychiatry. 2011;72(11):1452-1464. doi:10.408/JCP.1m06878 PubMed
14. Suppes T, Dennehy EB, Hirschfeld R M A, et al; Texas Consensus Conference Panel on Medication Treatment of Bipolar Disorder. The Texas implementation of medication algorithms: update to the algorithms for treatment of bipolar I disorder. J Clin Psychiatry. 2005;66(7):870-886. doi:10.408/JCP.v6n0710 PubMed
15. Nierenberg AA, Sylvia LG, Leon AC, et al; Bipolar CHOICE Study Group. Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder. Clin Trials. 2014;11(1):114-127. doi:10.17/174074513512184 PubMed
16. Guy W. ECDEU Assessment Manuel for Psychopharmacology, Revised. Washington, DC: US Government Printing Office; 1976.
17. Feighner JP, Jacobs RS, Jackson RE, et al. A double-blind comparative trial with mianserin and amitriptyline in outpatients with major depressive disorders. Br J Clin Pharmacol. 1983;15(suppl 2):227S-237S. doi:10.1/j.1365-2125.1983.tb05870.x PubMed
18. Spearing MK, Post RM, Leverich GS, et al. Modification of the Clinical Global Impressions (CGI) Scale for use in bipolar illness (BP): the CGI-BP. Psychiatry Res. 1997;73(3):159-171. doi:10.1016/S0165-1781 (97) 0123-6 PubMed
19. Reilly-Harrington NA, Sylvia LG, Leon AC, et al. The Medication Recommendation Tracking Form: a novel tool for tracking changes in prescribed medication, clinical decision making, and use in comparative effectiveness research. J Psychiatr Res. 2013;47(11):1686-1693. doi:10.1016/j.jpsychires.2013.07.09 PubMed
20. Kagan A, Dawber TR, Kannel WB, et al. The Framingham study: a prospective study of coronary heart disease. Fed Proc. 1962;21(4):52-57.
21. Leon AC, Solomon DA, Mueller TI, et al. A brief assessment of psychosocial functioning of subjects with bipolar I disorder: the LIFE-RIFT, Longitudinal Interval Follow-up Evaluation-Range Impaired Functioning Tool. J Nerv Ment Dis. 2000;188(12):805-812.
22. Endicott J, Nee J, Harrison W, et al. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-326.
23. Bowden CL, Singh V, Thompson P, et al. Development of the Bipolar Inventory of Symptoms Scale. Acta Psychiatr Scand. 2007;116(3):189-194. doi:10.1/j.160-047.206.095.x PubMed
24. Gonzalez JM, Bowden CL, Katz MM, et al. Development of the Bipolar Inventory of Symptoms Scale: concurrent validity, discriminant validity and retest reliability. Int J Methods Psychiatr Res. 2008;17(4):198-209. doi:10.102/mpr.262 PubMed
25. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134(4):382-389. doi:10.192/bjp. 134.4.382 PubMed
26. Young RC, Biggs JT, Ziegler VE, et al. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978;133(5):429-435. doi:10.192/bjp. 13.5.429 PubMed
27. Morris DW, Trivedi MH, Husain MM, et al. Indicators of pretreatment suicidal ideation in adults with major depressive disorder. Acta Psychiatr Scand. 2010;121(6):480-484. doi:10.1/j.160-047.209.01516.x PubMed
28. Posner K, Brent D, Lucas C, et al. Columbia-Suicide Severity Rating Scale (C-SSRS). New York, NY: New York State Psychiatric Institute; 2009.
29. Wisniewski SR, Rush AJ, Balasubramani GK, et al; STARD Investigators. Self-rated global measure of the frequency, intensity, and burden of side effects. J Psychiatr Pract. 2006;12(2):71-79.
30. Leon AC, Demirtas H, Hedeker D. Bias reduction with an adjustment for participants' intent to dropout of a randomized controlled clinical trial. Clin Trials. 2007;4(5):540-547. doi:10.17/174074507083871 PubMed
31. Hedeker D, Gibbons RD. Application of random-effects pattern-mixture models for missing data in longitudinal studies. Psychol Methods. 1997;2(1):64-78. doi:10.1037/1082-989X.2.1.64
32. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982;38(4):963-974. doi:10.2307/2529876 PubMed
33. Rabideau DJ, Nierenberg AA, Sylvia LG, et al. A novel application of the Intent to Attend assessment to reduce bias due to missing data in a randomized controlled clinical trial. Clin Trials. 2014;11(4):494-502. doi:10.17/174074514531096 PubMed
34. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M. I. N. I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl 20):22-33, quiz 34-57.
35. Hirschfeld RM, Weisler RH, Raines SR, et al; BOLDER Study Group. Quetiapine in the treatment of anxiety in patients with bipolar I or II depression: a secondary analysis from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2006;67(3):355-362.
36. Sheehan DV, Harnett-Sheehan K, Hidalgo RB, et al. Randomized, placebo-controlled trial of quetiapine XR and divalproex ER monotherapies in the treatment of the anxious bipolar patient. J Affect Disord. 2013;145(1):83-94. doi:10.1016/j.jad.2012.07.016 PubMed
37. Cipriani A, Hawton K, Stockton S, et al. Lithium in the prevention of suicide in mood disorders: updated systematic review and meta-analysis. BMJ. 2013;346:f3646. doi:10.136/bmj.f3646 PubMed
38. Baldessarini R, Henk H, Sklar A, et al. Psychotropic medications for patients with bipolar disorder in the United States: polytherapy and adherence. Psychiatr Serv. 2008;59(10):1175-1183. doi:10.176/ps.208.59.10.175 PubMed
39. Bauer M, Glenn T, Alda M, et al. Drug treatment patterns in bipolar disorder: analysis of long-term self-reported data. Int J Bipolar Disord. 2013;1(1):5. doi:10.186/2194-751-1-5 PubMed
40. Perlis RH, Ostacher MJ, Patel JK, et al. Predictors of recurrence in bipolar disorder: primary outcomes from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Am J Psychiatry. 2006;163(2):217-224. doi:10.176/api.ajp. 163.2.217 PubMed
41. Nierenberg AA, Friedman ES, Bowden CL, et al. Lithium treatment moderate-dose use study (LiTMUS) for bipolar disorder: a randomized comparative effectiveness trial of optimized personalized treatment with and without lithium. Am J Psychiatry. 2013;170(1):102-110. doi:10.176/api.ajp. 2012.12060751 PubMed