Improving the design of maintenance studies for bipolar disorder

Michael J. Gitlin, Osama Abulseoud, Mark A Frye

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1835-1842
Number of pages8
JournalCurrent Medical Research and Opinion
Volume26
Issue number8
DOIs
StatePublished - Aug 2010

Fingerprint

Bipolar Disorder
Maintenance
Random Allocation
PubMed
Consensus
Outcome Assessment (Health Care)
Recurrence
Therapeutics

Keywords

  • Bipolar disorder
  • Bipolar maintenance therapy
  • Pharmacotherapy
  • Relapse
  • Stabilization

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Improving the design of maintenance studies for bipolar disorder. / Gitlin, Michael J.; Abulseoud, Osama; Frye, Mark A.

In: Current Medical Research and Opinion, Vol. 26, No. 8, 08.2010, p. 1835-1842.

Research output: Contribution to journalArticle

Gitlin, Michael J. ; Abulseoud, Osama ; Frye, Mark A. / Improving the design of maintenance studies for bipolar disorder. In: Current Medical Research and Opinion. 2010 ; Vol. 26, No. 8. pp. 1835-1842.
@article{3316fd8656584bdcb843d2d1c828b3d9,
title = "Improving the design of maintenance studies for bipolar disorder",
abstract = "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.",
keywords = "Bipolar disorder, Bipolar maintenance therapy, Pharmacotherapy, Relapse, Stabilization",
author = "Gitlin, {Michael J.} and Osama Abulseoud and Frye, {Mark A}",
year = "2010",
month = "8",
doi = "10.1185/03007995.2010.489830",
language = "English (US)",
volume = "26",
pages = "1835--1842",
journal = "Current Medical Research and Opinion",
issn = "0300-7995",
publisher = "Informa Healthcare",
number = "8",

}

TY - JOUR

T1 - Improving the design of maintenance studies for bipolar disorder

AU - Gitlin, Michael J.

AU - Abulseoud, Osama

AU - Frye, Mark A

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

UR - http://www.scopus.com/inward/record.url?scp=77954738014&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77954738014&partnerID=8YFLogxK

U2 - 10.1185/03007995.2010.489830

DO - 10.1185/03007995.2010.489830

M3 - Article

C2 - 20515320

AN - SCOPUS:77954738014

VL - 26

SP - 1835

EP - 1842

JO - Current Medical Research and Opinion

JF - Current Medical Research and Opinion

SN - 0300-7995

IS - 8

ER -