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Lithium treatment moderate-dose use study (LiTMUS) for bipolar disorder: a randomized comparative effectiveness trial of optimized personalized treatment with and without lithium.

Publication ,  Journal Article
Nierenberg, AA; Friedman, ES; Bowden, CL; Sylvia, LG; Thase, ME; Ketter, T; Ostacher, MJ; Leon, AC; Reilly-Harrington, N; Iosifescu, DV ...
Published in: Am J Psychiatry
January 2013

OBJECTIVE: Lithium salts, once the mainstay of therapy for bipolar disorder, have tolerability issues at a higher dosage that often limit adherence. The authors investigated the comparative effectiveness of more tolerable dosages of lithium as part of optimized personalized treatment (OPT). METHOD: The authors randomly assigned 283 bipolar disorder outpatients to 6 months of open, flexible, moderate dosages of lithium plus OPT or to 6 months of OPT alone. The primary outcome measures were the Clinical Global Impression Scale for Bipolar Disorder-Severity (CGI-BP-S) and "necessary clinical adjustments" (medication adjustments per month). Secondary outcome measures included mood symptoms and functioning. The authors also assessed sustained remission (defined as a CGI-BP-S score ≤2 for 2 months) and treatment with second-generation antipsychotics. The authors hypothesized that lithium plus OPT would result in greater clinical improvement and fewer necessary clinical adjustments. RESULTS: The authors observed no statistically significant advantage of lithium plus OPT on CGI-BP-S scores, necessary clinical adjustments, or proportion with sustained remission. Both groups had similar outcomes across secondary clinical and functional measures. Fewer patients in the lithium-plus-OPT group received second-generation antipsychotics compared with the OPT-only group (48.3% and 62.5%, respectively). CONCLUSIONS: In this pragmatic comparative effectiveness study, a moderate but tolerated dosage of lithium plus OPT conferred no symptomatic advantage when compared with OPT alone, but the lithium-plus-OPT group had less exposure to second-generation antipsychotics. Only about one-quarter of patients in both groups achieved sustained remission of symptoms. These findings highlight the persistent and chronic nature of bipolar disorder as well as the magnitude of unmet needs in its treatment.

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Published In

Am J Psychiatry

DOI

EISSN

1535-7228

Publication Date

January 2013

Volume

170

Issue

1

Start / End Page

102 / 110

Location

United States

Related Subject Headings

  • Psychiatry
  • Psychiatric Status Rating Scales
  • Precision Medicine
  • Middle Aged
  • Male
  • Lithium Carbonate
  • Humans
  • Follow-Up Studies
  • Female
  • Dose-Response Relationship, Drug
 

Citation

APA
Chicago
ICMJE
MLA
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Nierenberg, A. A., Friedman, E. S., Bowden, C. L., Sylvia, L. G., Thase, M. E., Ketter, T., … Calabrese, J. R. (2013). 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, 170(1), 102–110. https://doi.org/10.1176/appi.ajp.2012.12060751
Nierenberg, Andrew A., Edward S. Friedman, Charles L. Bowden, Louisa G. Sylvia, Michael E. Thase, Terence Ketter, Michael J. Ostacher, 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 170, no. 1 (January 2013): 102–10. https://doi.org/10.1176/appi.ajp.2012.12060751.
Nierenberg AA, Friedman ES, Bowden CL, Sylvia LG, Thase ME, Ketter T, 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 Jan;170(1):102–10.
Nierenberg, Andrew A., 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, vol. 170, no. 1, Jan. 2013, pp. 102–10. Pubmed, doi:10.1176/appi.ajp.2012.12060751.
Nierenberg AA, Friedman ES, Bowden CL, Sylvia LG, Thase ME, Ketter T, Ostacher MJ, Leon AC, Reilly-Harrington N, Iosifescu DV, Pencina M, Severe JB, Calabrese JR. 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 Jan;170(1):102–110.
Journal cover image

Published In

Am J Psychiatry

DOI

EISSN

1535-7228

Publication Date

January 2013

Volume

170

Issue

1

Start / End Page

102 / 110

Location

United States

Related Subject Headings

  • Psychiatry
  • Psychiatric Status Rating Scales
  • Precision Medicine
  • Middle Aged
  • Male
  • Lithium Carbonate
  • Humans
  • Follow-Up Studies
  • Female
  • Dose-Response Relationship, Drug