Abstract
Background Little is known about the longer-term effects of adjunctive benzodiazepines on symptom response during treatment in patients with bipolar disorders. Methods The study sample consisted of 482 patients with bipolar I or II disorder enrolled in a 6-month, randomized, multi-site comparison of lithium- and quetiapine-based treatment. Changes in clinical measures (BISS total and subscales, CGI-BP, and CGI-Efficacy Index) were compared between participants who did and did not receive benzodiazepine treatment at baseline or during follow-up. Selected outcomes were also compared between patients who did and did not initiate benzodiazepines during follow-up using stabilized inverse probability weighted analyses. Results Significant improvement in all outcome measures occurred within each benzodiazepine exposure group. Benzodiazepine users (at baseline or during follow-up) experienced significantly less improvement in BISS total, BISS irritability, and CGI-BP scores than did benzodiazepine non-users. There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses. There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders. Limitations This is a secondary analysis of data from a randomized effectiveness trial that was not designed to address differential treatment response according to benzodiazepine use. Conclusions Adjunctive benzodiazepines may not significantly affect clinical outcome in lithium- or quetiapine-treated patients with bipolar I or II disorder over 6 months, after controlling for potential confounding factors.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 30-35 |
| Number of pages | 6 |
| Journal | Journal of Affective Disorders |
| Volume | 161 |
| DOIs | |
| State | Published - Jun 1 2014 |
Keywords
- Benzodiazepines
- Bipolar disorder
- Clinical outcome
- Lithium
- Quetiapine
ASJC Scopus subject areas
- Clinical Psychology
- Psychiatry and Mental health
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Effect of adjunctive benzodiazepines on clinical outcomes in lithium- or quetiapine-treated outpatients with bipolar i or II disorder : Results from the Bipolar CHOICE trial. / Bobo, William V.; Reilly-Harrington, Noreen A.; Ketter, Terence A.; Brody, Benjamin D.; Kinrys, Gustavo; Kemp, David E.; Shelton, Richard C.; McElroy, Susan L.; Sylvia, Louisa G.; Kocsis, James H.; McInnis, Melvin G.; Friedman, Edward S.; Singh, Vivek; Tohen, Mauricio; Bowden, Charles L.; Deckersbach, Thilo; Calabrese, Joseph R.; Thase, Michael E.; Nierenberg, Andrew A.; Rabideau, Dustin J.; Schoenfeld, David A.; Faraone, Stephen V.; Kamali, Masoud.
In: Journal of Affective Disorders, Vol. 161, 01.06.2014, p. 30-35.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Effect of adjunctive benzodiazepines on clinical outcomes in lithium- or quetiapine-treated outpatients with bipolar i or II disorder
T2 - Results from the Bipolar CHOICE trial
AU - Bobo, William V.
AU - Reilly-Harrington, Noreen A.
AU - Ketter, Terence A.
AU - Brody, Benjamin D.
AU - Kinrys, Gustavo
AU - Kemp, David E.
AU - Shelton, Richard C.
AU - McElroy, Susan L.
AU - Sylvia, Louisa G.
AU - Kocsis, James H.
AU - McInnis, Melvin G.
AU - Friedman, Edward S.
AU - Singh, Vivek
AU - Tohen, Mauricio
AU - Bowden, Charles L.
AU - Deckersbach, Thilo
AU - Calabrese, Joseph R.
AU - Thase, Michael E.
AU - Nierenberg, Andrew A.
AU - Rabideau, Dustin J.
AU - Schoenfeld, David A.
AU - Faraone, Stephen V.
AU - Kamali, Masoud
N1 - Funding Information: Dr. Brody has received salary support over the past 3 years from Grants funded by Forrest, Agency for Healthcare Quality and Research , and Pritzker Neuropsychiatric Disorders Research Consortium . Funding Information: Dr. Kinrys has received research support from AstraZeneca , Bristol‐Myers Squibb Foundation , Cephalon , Elan Pharmaceuticals , Eli Lilly & Company , Forest Pharmaceuticals Inc. , GlaxoSmithkline , Sanofi/Synthelabo , Sepracor Inc., Pfizer Inc., UCB Pharma , and Wyeth-Ayerst Laboratories . He has been an advisor or consultant for Astra-Zeneca, Cephalon, Eli Lilly & Company, Forest Pharmaceuticals Inc., GlaxoSmithkline, Janssen Pharmaceutica, Pfizer Inc, Sepracor Inc., UCB Pharma, and Wyeth-Ayerst Laboratories. Dr. Kinrys has been a speaker for Astra-Zeneca, Forest Pharmaceuticals Inc., GlaxoSmithkline, Sepracor Inc., and Wyeth-Ayerst Laboratories. Funding Information: Dr. Friedman r eceives Grant support from Repligen , AstraZeneca , Roche , Takeda , Neosync . He has been a consultant for Pamlab. He receives royalties from Springer. He has served as an expert forensic consultant for Thomson Rhodes & Cowie P.C. and Berger and Zavesky Co. L.P.A. Funding Information: Dr. Kocsis has received research Grants and contracts from AHRQ , NIMH , NIDA , Burroughs Wellcome Fund , Pritzker Consortium , Takeda , Forest , AstraZeneca , and Roche . He is on the speaker׳s bureau at Pfizer and Merck and on the advisory board at Corcept. Funding Information: Dr. Shelton has served as a consultant to Bristol-Myers Squibb, Cyberonics, Inc., Elan, Corp., Eli Lilly and Company, Euthymics Bioscience, Forest Pharmaceuticals, Janssen Pharmaceutica, Medtronic, Inc., Otsuka Pharmaceuticals, Pamlab, Inc., Pfizer, Inc., Ridge Diagnostics, Takeda Pharmaceuticals. Dr. Shelton has received research Grant support from Appian Labs , Bristol‐Myers Squibb Foundation , Elan, Corp. , Eli Lilly and Company , Euthymics Bioscience , Forest Pharmaceuticals , Janssen Pharmaceutica , Naurex, Inc. , Novartis Pharmaceuticals, Otsuka Pharmaceuticals , Pamlab, Inc. , Repligen, Corp. , Ridge Diagnostics , St. Jude Medical Inc., Takeda Pharmaceuticals . Funding Information: Dr. McElroy is a consultant to or member of the scientific advisory boards of Alkermes, Bracket, Corcept, MedAvante, Shire, Sunovian, and Teva. She is a principal or co-investigator on studies sponsored by the Agency for Healthcare Research & Quality (AHRQ) , Alkermes , AstraZeneca , Cephalon , Eli Lilly and Company and Company, Forest, Marriott Foundation , National Institute of Mental Health , Orexigen Therapeutics, Inc. , Pfizer , Shire , Takeda Pharmaceutical Company Ltd. , and Transcept Pharmaceutical, Inc . She is also an inventor on United States Patent no. 6,323,236 B2, Use of Sulfamate Derivatives for Treating Impulse Control Disorders, and along with the patent′s assignee, University of Cincinnati, Cincinnati, Ohio, has received payments from Johnson & Johnson, which has exclusive rights under the patent. Funding Information: Dr. Kocsis has received research Grants and contracts from AHRQ , NIMH , NIDA , Burroughs Wellcome Fund , Pritzker Consortium , Takeda , Forest , AstraZeneca , Roche . He is on the speaker′s bureau at Pfizer and Merck and on the advisory board at Corcept. Funding Information: Dr. McInnis has received Grants for research support from NIMH , the Heinz C Prechter Research Fund , and the Michigan Institute for Clinical Health Research (MICHR). MM has received consulting income from the Qatar National Research Foundation and Merck Pharmaceuticals. Funding Information: Dr. Freedman received Grant support from NIMH , AHRQ , Novartis , St. Jude Medical , Medtronics , Repligen , AstraZeneca , Roche , and Takeda . He receives royalties from Springer. He has been a consultant for PamLab. Funding Information: Dr. Deckersbach has received research support from NIMH , NARSAD , TSA , OCF , Tufts University , NIH , NIA , Janssen Pharmaceuticals , the Forest Research Institute , Shire Development Inc. , Medtronic , Cyberonics , Northstar . He has received honoraria, consultation fees and/or royalties from the following: Medacorp, MGH Psychiatry Academy, BrainCells Inc., Systems Research and Applications Corporation, Boston University, Tufts University, the Catalan Agency for Health Technology Assessment and Research, the National Association of Social Workers Massachusetts, the Massachusetts Medical Society, and Oxford University Press. Funding Information: Dr. Calabrese receives federal funding from the Department of Defense, Health Resources Services Administration, and NIMH; he receives research funding or Grants from the following private industries or nonprofit funds: The Cleveland Foundation , NARSAD , and Stanley Medical Research Institute ; he receives research Grants from Abbott Fund , AstraZeneca , Cephalon , GlaxoSmithKline , Janssen , Eli Lilly and Company , and Lundbeck ; he serves on the advisory boards of Abbott, AstraZeneca, Bristol-Myers Squibb, Dainippon Sumitomo Pharma, Forest, France Foundation, GlaxoSmithKline, Janssen, NeuroSearch, OrthoMcNeil, Repligen, Schering-Plough, Servier, Solvay/Wyeth, Takeda, and Supernus Pharmaceuticals; and he reports CME activities with AstraZeneca, Bristol-Myers Squibb, France Foundation, GlaxoSmithKline, Janssen, Johnson & Johnson, Schering-Plough, and Solvay/Wyeth. Funding Information: Dr. Thase has been an advisor/consultant: to Alkermes, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Janssen Pharmaceuticals, Lundbeck, MedAvante, Merck, Mylan, Neuronetics, Otsuka, Pamlab, PharmaNeuroboost, Pfizer, Rexahn, Roche, Shire, Sunovion, Supernus, Takeda, and Teva, as well as the US Food and Drug Administration and the National Institute of Mental Health. During the same time frame, Dr. Thase has received honoraria for talks from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Merck, and Pfizer and he has received research grants from Alkermes, AstraZeneca, Eli Lilly, Forest, GlaxoSmithKline, Otsuka, PharmaNeuroboost, and Roche, as well as the National Institute of Mental Health and the Agency for Healthcare Research and Quality. Funding Information: Dr. Nierenberg is a consultant for Abbott Laboratories, Astra Zeneca, Basilea, BrainCells Inc., Brandeis University, Bristol-Myers Squibb, Cephalon, Corcept, Eli Lilly & Co., Forest, Genaissance, GlaxoSmithKline, Innapharma, Janssen Pharmaceutica, Jazz Pharmaceuticals, Lundbeck, Merck, Novartis, PamLabs, PGx Health, Pfizer, Ridge Diagnostics, Roche, Sepracor, Schering-Plough, Shire, Somerset, Sunovion, Takeda, Targacept, and Teva. He is a stakeholder in Appliance Computing, Inc. (MindSite); Brain Cells, Inc., InfoMed (potential share of income). He receives research support from AHRQ , Bristol‐Myers Squibb Foundation , Cederroth , Cyberonics , Elan , Forest Pharmaceuticals , GlaxoSmithKline , Janssen Pharmaceutica , Lichtwer Pharma , Eli Lilly and Company , Mylin (formerly Dey Pharmaceuticals), NARSAD , NIMH , Pamlabs , Pfizer , Shire , Stanley Foundation , and Wyeth-Ayerst . Honoraria include MGH Psychiatry Academy in the past 3 years (Prior to 3 years ago, honoraria from Bristol-Myers Squibb, Cyberonics, Forest Pharmaceuticals, GlaxoSmithKline, Eli Lilly, Shire, Wyeth-Ayerst). Dr. Nierenberg receives other income from legal case reviews for CRICO, MBL Publishing for past services as Editor-in-chief of CNS Spectrums, Slack Inc. for services as Associate Editor of Psychiatric Annals, and Editorial Board, Mind Mood Memory, Belvior Publications. He has copyright joint ownership with MGH for Structured Clinical Interview for MADRS and Clinical Positive Affect Scale and additional honoraria from ADURS, American Society for Clinical Psychopharmacology and Zucker Hillside Hospital and Forest and Janssen, Biomedical Development, Boston Center for the Arts, University of Pisa, University of Wisconsin at Madison, University Texas Southwest at Dallas, Health New England and Harold Grinspoon Charitable Foundation and Eli Lilly and AstraZeneca, Brandeis University, International Society for Bipolar Disorder, 2nd East Asian Bipolar Forum, Mid-Atlantic Permanente Research Institute, Up-to-Date. Funding Information: This study was funded by AHRQ Grant R01 HS019371-01 . Dr. Bobo was supported, in part, by NIMH Grant MH087747 .
PY - 2014/6/1
Y1 - 2014/6/1
N2 - Background Little is known about the longer-term effects of adjunctive benzodiazepines on symptom response during treatment in patients with bipolar disorders. Methods The study sample consisted of 482 patients with bipolar I or II disorder enrolled in a 6-month, randomized, multi-site comparison of lithium- and quetiapine-based treatment. Changes in clinical measures (BISS total and subscales, CGI-BP, and CGI-Efficacy Index) were compared between participants who did and did not receive benzodiazepine treatment at baseline or during follow-up. Selected outcomes were also compared between patients who did and did not initiate benzodiazepines during follow-up using stabilized inverse probability weighted analyses. Results Significant improvement in all outcome measures occurred within each benzodiazepine exposure group. Benzodiazepine users (at baseline or during follow-up) experienced significantly less improvement in BISS total, BISS irritability, and CGI-BP scores than did benzodiazepine non-users. There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses. There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders. Limitations This is a secondary analysis of data from a randomized effectiveness trial that was not designed to address differential treatment response according to benzodiazepine use. Conclusions Adjunctive benzodiazepines may not significantly affect clinical outcome in lithium- or quetiapine-treated patients with bipolar I or II disorder over 6 months, after controlling for potential confounding factors.
AB - Background Little is known about the longer-term effects of adjunctive benzodiazepines on symptom response during treatment in patients with bipolar disorders. Methods The study sample consisted of 482 patients with bipolar I or II disorder enrolled in a 6-month, randomized, multi-site comparison of lithium- and quetiapine-based treatment. Changes in clinical measures (BISS total and subscales, CGI-BP, and CGI-Efficacy Index) were compared between participants who did and did not receive benzodiazepine treatment at baseline or during follow-up. Selected outcomes were also compared between patients who did and did not initiate benzodiazepines during follow-up using stabilized inverse probability weighted analyses. Results Significant improvement in all outcome measures occurred within each benzodiazepine exposure group. Benzodiazepine users (at baseline or during follow-up) experienced significantly less improvement in BISS total, BISS irritability, and CGI-BP scores than did benzodiazepine non-users. There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses. There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders. Limitations This is a secondary analysis of data from a randomized effectiveness trial that was not designed to address differential treatment response according to benzodiazepine use. Conclusions Adjunctive benzodiazepines may not significantly affect clinical outcome in lithium- or quetiapine-treated patients with bipolar I or II disorder over 6 months, after controlling for potential confounding factors.
KW - Benzodiazepines
KW - Bipolar disorder
KW - Clinical outcome
KW - Lithium
KW - Quetiapine
UR - http://www.scopus.com/inward/record.url?scp=84897455154&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84897455154&partnerID=8YFLogxK
U2 - 10.1016/j.jad.2014.02.046
DO - 10.1016/j.jad.2014.02.046
M3 - Article
C2 - 24751304
AN - SCOPUS:84897455154
VL - 161
SP - 30
EP - 35
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
SN - 0165-0327
ER -