Comparative Effectiveness Study for Bipolar Disorder

Summary

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

Timeline

Start

2010-09

Primary completion

2013-04

Completion

2013-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Li + APT vs QTP + APT; p = 0.59; Mixed Models Analysis NCT01331304 ↗

registry analysis (superiority or other test); Li + APT vs QTP + APT; p = 0.118; Wilcoxon (Mann-Whitney) NCT01331304 ↗

Publications

• Wrobel AL, Dean OM, Lotfaliany M, Berk M, Sylvia LG, Thase ME, Deckersbach T, Tohen M, McInnis MG, Kocsis JH, Shelton RC, McElroy SL, Turner A, Nierenberg AA. Potential Impact of Childhood Abuse on Quality of Life During Mood-Stabilising Treatment in Individuals Living With Bipolar Disorder. Bipolar Disord. 2026 Mar;28(2):e70079. doi: 10.1111/bdi.70079.
• Sylvia LG, Montana RE, Deckersbach T, Thase ME, Tohen M, Reilly-Harrington N, McInnis MG, Kocsis JH, Bowden C, Calabrese J, Gao K, Ketter T, Shelton RC, McElroy SL, Friedman ES, Rabideau DJ, Nierenberg AA. Poor quality of life and functioning in bipolar disorder. Int J Bipolar Disord. 2017 Dec;5(1):10. doi: 10.1186/s40345-017-0078-4. Epub 2017 Mar 27.
• Deckersbach T, Nierenberg AA, McInnis MG, Salcedo S, Bernstein EE, Kemp DE, Shelton RC, McElroy SL, Sylvia LG, Kocsis JH, Bobo WV, Friedman ES, Singh V, Tohen M, Bowden CL, Ketter TA, Calabrese JR, Thase ME, Reilly-Harrington NA, Rabideau DJ, Kinrys G, Kamali M. Baseline disability and poor functioning in bipolar disorder predict worse outcomes: results from the Bipolar CHOICE study. J Clin Psychiatry. 2016 Jan;77(1):100-8. doi: 10.4088/JCP.14m09210.
• 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. Bipolar CHOICE (Clinical Health Outcomes Initiative in Comparative Effectiveness): a pragmatic 6-month trial of lithium versus quetiapine for bipolar disorder. J Clin Psychiatry. 2016 Jan;77(1):90-9. doi: 10.4088/JCP.14m09349.
• Bobo WV, Reilly-Harrington NA, Ketter TA, Brody BD, Kinrys G, Kemp DE, Shelton RC, McElroy SL, Sylvia LG, Kocsis JH, McInnis MG, Friedman ES, Singh V, Tohen M, Bowden CL, Deckersbach T, Calabrese JR, Thase ME, Nierenberg AA, Rabideau DJ, Schoenfeld DA, Faraone SV, Kamali M. Complexity of illness and adjunctive benzodiazepine use in outpatients with bipolar I or II disorder: results from the Bipolar CHOICE study. J Clin Psychopharmacol. 2015 Feb;35(1):68-74. doi: 10.1097/JCP.0000000000000257.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lithium	Unknown	600 mg	—
Subject	Lithium	Unknown	900 mg	—
Subject	Quetiapine	Small molecule	100 mg	—
Subject	Quetiapine	Small molecule	800 mg	—

Indications