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Clinical predictors of non-response to lithium treatment in the Pharmacogenomics of Bipolar Disorder (PGBD) study. 2021
Yian Lin, and
Adam X Maihofer, and
Emma Stapp, and
Megan Ritchey, and
Ney Alliey-Rodriguez, and
Amit Anand, and
Yokesh Balaraman, and
Wade H Berrettini, and
Holli Bertram, and
Abesh Bhattacharjee, and
Cynthia V Calkin, and
Carla Conroy, and
William Coryell, and
Nicole D'Arcangelo, and
Anna DeModena, and
Joanna M Biernacka, and
Carrie Fisher, and
Nicole Frazier, and
Mark Frye, and
Keming Gao, and
Julie Garnham, and
Elliot Gershon, and
Kara Glazer, and
Fernando S Goes, and
Toyomi Goto, and
Elizabeth Karberg, and
Gloria Harrington, and
Petter Jakobsen, and
Masoud Kamali, and
Marisa Kelly, and
Susan G Leckband, and
Falk W Lohoff, and
Andrea Stautland, and
Michael J McCarthy, and
Melvin G McInnis, and
Francis Mondimore, and
Gunnar Morken, and
John I Nurnberger, and
Ketil J Oedegaard, and
Vigdis Elin Giever Syrstad, and
Kelly Ryan, and
Martha Schinagle, and
Helle Schoeyen, and
Ole A Andreassen, and
Marth Shaw, and
Paul D Shilling, and
Claire Slaney, and
Bruce Tarwater, and
Joseph R Calabrese, and
Martin Alda, and
Caroline M Nievergelt, and
Peter P Zandi, and
John R Kelsoe
Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Lithium is regarded as a first-line treatment for bipolar disorder (BD), but partial response and non-response commonly occurs. There exists a need to identify lithium non-responders prior to initiating treatment. The Pharmacogenomics of Bipolar Disorder (PGBD) Study was designed to identify predictors of lithium response. The PGBD Study was an eleven site prospective trial of lithium treatment in bipolar I disorder. Subjects were stabilized on lithium monotherapy over 4 months and gradually discontinued from all other psychotropic medications. After ensuring a sustained clinical remission (defined by a score of ≤3 on the CGI for 4 weeks) had been achieved, subjects were followed for up to 2 years to monitor clinical response. Cox proportional hazard models were used to examine the relationship between clinical measures and time until failure to remit or relapse. A total of 345 individuals were enrolled into the study and included in the analysis. Of these, 101 subjects failed to remit or relapsed, 88 achieved remission and continued to study completion, and 156 were terminated from the study for other reasons. Significant clinical predictors of treatment failure (p < 0.05) included baseline anxiety symptoms, functional impairments, negative life events and lifetime clinical features such as a history of migraine, suicidal ideation/attempts, and mixed episodes, as well as a chronic course of illness. In this PGBD Study of lithium response, several clinical features were found to be associated with failure to respond to lithium. Future validation is needed to confirm these clinical predictors of treatment failure and their use clinically to distinguish who will do well on lithium before starting pharmacotherapy.
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