TY - JOUR
T1 - Improving the design of maintenance studies for bipolar disorder
AU - Gitlin, Michael J.
AU - Abulseoud, Osama
AU - Frye, Mark A.
N1 - Funding Information:
Linda Felcone has provided editorial and writing support to facilitate the multiple drafts and revisions of the manuscript that authors have contributed for the submission. Linda Felcone followed the authors’ instructions in both preparation of the drafts and the revisions. Funding for the editorial support was provided by Bristol-Myers Squibb. Editorial help was also supplied by MedErgy HealthGroup, Inc. in drafting Figure 1; this was funded by Bristol-Myers Squibb.
PY - 2010/8
Y1 - 2010/8
N2 - Background: In contrast to the trial design of acute mania studies, there is no standard design for bipolar maintenance studies. Over the past 15 years, the design of monotherapy maintenance studies in bipolar disorder has evolved significantly, but recent study designs continue to differ in important ways. Scope: We reviewed the design of recent controlled bipolar maintenance studies, using PubMed, from August 2006 to August 2009, examining the strengths and weaknesses of different study design features. Findings: Design differences are sufficiently important that the disparate results across maintenance studies may reflect either true differences in medication efficacy or the effects of these design differences on outcome. Design elements such as recent episode polarity, stabilization criteria, using enriched versus nonenriched samples, length of stabilization before randomization, length of experimental phase, and recurrence outcome criteria are critical factors that differ widely across studies and likely play a role in study outcome. Conclusions: As consensus for trial designs for bipolar maintenance therapy is developed, it will be easier to develop algorithms for maintenance treatment based on results from studies as opposed to clinical opinions.
AB - Background: In contrast to the trial design of acute mania studies, there is no standard design for bipolar maintenance studies. Over the past 15 years, the design of monotherapy maintenance studies in bipolar disorder has evolved significantly, but recent study designs continue to differ in important ways. Scope: We reviewed the design of recent controlled bipolar maintenance studies, using PubMed, from August 2006 to August 2009, examining the strengths and weaknesses of different study design features. Findings: Design differences are sufficiently important that the disparate results across maintenance studies may reflect either true differences in medication efficacy or the effects of these design differences on outcome. Design elements such as recent episode polarity, stabilization criteria, using enriched versus nonenriched samples, length of stabilization before randomization, length of experimental phase, and recurrence outcome criteria are critical factors that differ widely across studies and likely play a role in study outcome. Conclusions: As consensus for trial designs for bipolar maintenance therapy is developed, it will be easier to develop algorithms for maintenance treatment based on results from studies as opposed to clinical opinions.
KW - Bipolar disorder
KW - Bipolar maintenance therapy
KW - Pharmacotherapy
KW - Relapse
KW - Stabilization
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U2 - 10.1185/03007995.2010.489830
DO - 10.1185/03007995.2010.489830
M3 - Short survey
C2 - 20515320
AN - SCOPUS:77954738014
SN - 0300-7995
VL - 26
SP - 1835
EP - 1842
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 8
ER -