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


METHODS
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.
Young
Robert C
RC
Institute of Geriatric Psychiatry, Weill Cornell Medical College, White Plains, NY 10605, USA. ryoung@med.cornell.edu
Schulberg
Herbert C
HC
Gildengers
Ariel G
AG
Sajatovic
Martha
M
Mulsant
Benoit H
BH
Gyulai
Laszlo
L
Beyer
John
J
Marangell
Lauren
L
Kunik
Mark
M
Ten Have
Thomas
T
Bruce
Martha L
ML
Gur
Ruben
R
Marino
Patricia
P
Evans
Jovier D
JD
Reynolds
Charles F
CF
Alexopoulos
George S
GS
D000928:Antidepressive Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D019317:Evidence-Based Medicine; D005853:Geriatrics; D017408:Guidelines as Topic; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods / Q000592:standards; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards*; D012107:Research Design / Q000592:standards*; D016896:Treatment Outcome
D000928:Antidepressive Agents