Clinical predictors of non-response to lithium treatment in the Pharmacogenomics of Bipolar Disorder (PGBD) study.
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Lin Yian, Maihofer Adam X, Stapp Emma, Ritchey Megan, Alliey-Rodriguez Ney, Anand Amit, Balaraman Yokesh, Berrettini Wade H, Bertram Holli, Bhattacharjee Abesh, Calkin Cynthia V, Conroy Carla, Coryell William, D'Arcangelo Nicole, DeModena Anna, Biernacka Joanna M, Fisher Carrie, Frazier Nicole, Frye Mark, Gao Keming, Garnham Julie, Gershon Elliot, Glazer Kara, Goes Fernando S, Goto Toyomi, Karberg Elizabeth, Harrington Gloria, Jakobsen Petter, Kamali Masoud, Kelly Marisa, Leckband Susan G, Lohoff Falk W, Stautland Andrea, McCarthy Michael J, McInnis Melvin G, Mondimore Francis, Morken Gunnar, Nurnberger John I, Oedegaard Ketil J, Syrstad Vigdis Elin Giever, Ryan Kelly, Schinagle Martha, Schoeyen Helle, Andreassen Ole A, Shaw Marth, Shilling Paul D, Slaney Claire, Tarwater Bruce, Calabrese Joseph R, Alda Martin, Nievergelt Caroline M, Zandi Peter P, Kelsoe John R
Аннотация
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.