Conceptual and methodological issues in designing a randomized, controlled treatment trial for geriatric bipolar disorder: GERI-BD

Authors


  • Janssen has provided risperidone to some sites for GERI-BD. RCY has received research support from GlaxoSmithKline and AstraZeneca. AGG has participated in scientific advisory board meetings for Shire Pharmaceuticals and he is a minor stockholder of Eli Lilly & Company. MS has received research support from GlaxoSmithKline and is a consultant and member of the speakers bureau of AstraZeneca. LM has received grant/research support from Bristol-Meyers Squibb, Eli Lilly & Co., and Sanofi-aventis; and has received consultant/honoraria from GlaxoSmithKline and Novartis. RG has received grant support from AstraZeneca and is a consultant to Merck. CFR has received research support from GlaxoSmithKline, Forest, Pfizer, Eli Lilly & Co., and Bristol-Meyers Squibb. GSA has received research grants from Cephalon and Forest; has served on the scientific advisory boards of Forest, Sanofi-aventis, and Novartis; and is on the speakers bureau of Cephalon, Forest, Eli Lilly & Co., Bristol-Meyers Squibb, GlaxoSmithKline, Pfizer, and Janssen. HCS, BHM, LG, JB, MK, TTH, MLB, PM, and JDE report no conflicts of interest.

Corresponding author:
Robert C. Young, M.D.
Weill Cornell Medical College
21 Bloomingdale Road
White Plains, NY 10605, USA
Fax: 914-997-5958
E-mail: ryoung@med.cornell.edu

Abstract

Young RC, Schulberg HC, Gildengers AG, Sajatovic M, Mulsant BH, Gyulai L, Beyer J, Marangell L, Kunik M, Ten Have T, Bruce ML, Gur R, Marino P, Evans JD, Reynolds CF III, Alexopoulos GS. Conceptual and methodological issues in designing a randomized, controlled treatment trial for geriatric bipolar disorder: GERI-BD.
Bipolar Disord 2010: 12: 56–67. © 2010 The Authors.
Journal compilation © 2010 John Wiley & Sons A/S.

Aim:  This report considers the conceptual and methodological concerns confronting clinical investigators seeking to generate knowledge regarding the tolerability and benefits of pharmacotherapy in geriatric bipolar disorder (BD) patients.

Method:  There is continuing need for evidence-based guidelines derived from randomized controlled trials that will enhance drug treatment of geriatric BD patients. Therefore, we present the complex conceptual and methodological choices encountered in designing a multisite clinical trial and the decisions reached by the investigators with the intention that study findings be pertinent to, and can facilitate, routine treatment decisions.

Results:  Guided by a literature review and input from peers, the tolerability and antimanic effects of lithium and valproate were judged to be the key mood stabilizers to investigate with regard to treating bipolar I disorder manic, mixed, and hypomanic states. The patient selection criteria are intended to generate a sample that not only experiences common treatment needs but also represents the variety of older patients seen in university-based clinical settings. The clinical protocol guides titration of lithium and valproate to target serum concentrations, with lower levels allowed when necessitated by limited tolerability. The protocol emphasizes initial monotherapy. However, augmentation with risperidone is permitted after three weeks when indicated by operational criteria.

Conclusions:  A randomized, controlled trial that both investigates commonly prescribed mood stabilizers and maximizes patient participation can meaningfully address high-priority clinical concerns directly relevant to the routine pharmacologic treatment of geriatric BD patients.

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