PROJECT 1. Sequential Multiple Assignment /Randomized Treatment (SMART) for BD: C Bowden, V Singh, P Thompson, C Martinez, J Calabrese, K Gao, M Quinones, J Mintz, M Tohen. A . What we propose to do. This open methods advancement study will randomize BD patients with clinically significant symptoms to treatment with one of two mood stabilizers (MS), lithium [LI] or divalproex [DV]. Those who develop protocol defined depression will then be randomized to a MS alone, MS + quetiapine [QT] or MS + lamotrigine [LM]. A SMART strategy employs a rule for adding new treatments based on each patient's current illness state and response during the trial, mimicking the adaptive nature of treatment selection which occurs in clinical settings, but in a controlled way which allows application of causal inference. By using early indices of response to dynamically alter treatment decisions to improve outcome, SMART eliminates unmeasured confounders associated with treatment decisions that are not randomized, as occurs in data mining exercises and in other non-randomized decisions in studies which randomize one variable at baseline. This sequential adaptive design represents a methodological innovation in bipolar trial history which will have particular implications for effectiveness studies.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Center Core Grants (P30)
Project #
5P30MH086045-04
Application #
8730221
Study Section
Special Emphasis Panel (ZMH1)
Project Start
Project End
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
4
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of Texas Health Science Center
Department
Type
DUNS #
City
San Antonio
State
TX
Country
United States
Zip Code
78229
Fries, Gabriel R; Colpo, Gabriela D; Monroy-Jaramillo, Nancy et al. (2017) Distinct lithium-induced gene expression effects in lymphoblastoid cell lines from patients with bipolar disorder. Eur Neuropsychopharmacol 27:1110-1119
Tohen, Mauricio; Mintz, Jim; Bowden, Charles L (2016) Analysis of bipolar maintenance treatment with lithium versus olanzapine utilizing Multi-state Outcome Analysis of Treatments (MOAT). Bipolar Disord 18:282-7
Perlick, Deborah A; Berk, Lesley; Kaczynski, Richard et al. (2016) Caregiver burden as a predictor of depression among family and friends who provide care for persons with bipolar disorder. Bipolar Disord 18:183-91
Bowden, C L; Mintz, J; Tohen, M (2016) Multi-state outcome analysis of treatments (MOAT): application of a new approach to evaluate outcomes in longitudinal studies of bipolar disorder. Mol Psychiatry 21:237-42
Bowden, Charles L; Singh, Vivek (2016) The use of antidepressants in bipolar disorder patients with depression. Expert Opin Pharmacother 17:17-25
Arnold, Jodi Gonzalez; Martinez, Cervando; Zavala, Juan et al. (2016) Investigating symptom domains of bipolar disorder for Spanish-speakers using the Bipolar Inventory of Symptoms Scale. J Affect Disord 205:239-244
Gonzalez Arnold, Jodi; Salcedo, Stephanie; Ketter, Terrence A et al. (2015) An exploratory study of responses to low-dose lithium in African Americans and Hispanics. J Affect Disord 178:224-8
Bowden, Charles L (2015) Providing assessable information on effectiveness of maintenance treatments for bipolar disorder to psychiatrists and patients. Evid Based Ment Health 18:58
Singh, V; Bowden, C L; Gonzalez, J M et al. (2013) Discriminating primary clinical states in bipolar disorder with a comprehensive symptom scale. Acta Psychiatr Scand 127:145-52
Perlick, D A; Gonzalez, J; Michael, L et al. (2012) Rumination, gender, and depressive symptoms associated with caregiving strain in bipolar disorder. Acta Psychiatr Scand 126:356-62

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