Abstract
Background: Many mood disorder patients need analgesics due to increased pain sensitivity. Recent studies have suggested that nonsteroidal anti-inflammatory drugs (NSAIDs) may inhibit antidepressant treatment, which requires replication before clinical recommendations. Methods: The Clinical and Health Outcomes Initiatives in Comparative Effectiveness for Bipolar Disorder Study randomized participants to 6 months lithium or quetiapine treatment. Use of NSAIDs and paracetamol was assessed throughout the study period and psychopathology measured with the Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) and Bipolar Inventory of Symptoms Scale (BISS). The effects of NSAIDs and paracetamol on treatment outcome were examined using mixed effects linear regression adjusted for age, gender, body mass index, smoking status, exercise, and somatic diseases. Results: Among 482 participants, 177 (36.7%) used NSAIDs and/or paracetamol during the study. NSAID and paracetamol users did not differ from nonusers with respect to treatment outcome with lithium or quetiapine at any time point during 6 months treatment on the overall CGI-BP (β = 0.001 (95% CI = −0.01 to −0.01), P =.87), the BISS (β = 0.01 (95% CI = −0.17 to 0.15), P =.91), nor the CGI-BP subscales for depression or mania. Users of NSAIDs only (n = 76), paracetamol only (n = 62), and users of both NSAIDs and paracetamol (n = 39) showed no statistical difference compared to nonusers (all P >.3). Conclusions: This is the first trial to show that use of NSAIDs and paracetamol, alone or in combination, does not affect lithium- or quetiapine-based bipolar disorder mood-stabilizing treatment outcomes. Prior studies have suggested that NSAIDs may inhibit antidepressant treatment, whereas our results support findings indicating no detrimental effects of NSAIDs or paracetamol on affective disorder treatment.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 281-290 |
| Number of pages | 10 |
| Journal | Depression and Anxiety |
| Volume | 34 |
| Issue number | 3 |
| DOIs | |
| State | Published - Mar 1 2017 |
Keywords
- bipolar disorder
- lithium
- nonsteroidal anti-inflammatory drugs (NSAIDs)
- paracetamol
- polypharmacy
- quetiapine
ASJC Scopus subject areas
- Clinical Psychology
- Psychiatry and Mental health
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Nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol do not affect 6-month mood-stabilizing treatment outcome among 482 patients with bipolar disorder. / Köhler-Forsberg, Ole; Sylvia, Louisa; Thase, Michael; Calabrese, Joseph R.; Deckersbach, Thilo; Tohen, Mauricio; Bowden, Charles L.; McInnis, Melvin; Kocsis, James H.; Friedman, Edward S.; Ketter, Terence A.; McElroy, Susan; Shelton, Richard C.; Nierenberg, Andrew A.
In: Depression and Anxiety, Vol. 34, No. 3, 01.03.2017, p. 281-290.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol do not affect 6-month mood-stabilizing treatment outcome among 482 patients with bipolar disorder
AU - Köhler-Forsberg, Ole
AU - Sylvia, Louisa
AU - Thase, Michael
AU - Calabrese, Joseph R.
AU - Deckersbach, Thilo
AU - Tohen, Mauricio
AU - Bowden, Charles L.
AU - McInnis, Melvin
AU - Kocsis, James H.
AU - Friedman, Edward S.
AU - Ketter, Terence A.
AU - McElroy, Susan
AU - Shelton, Richard C.
AU - Nierenberg, Andrew A.
N1 - Funding Information: The authors would like to thank Dustin J. Rabideau for important statistical advice. Dr. Sylvia was a shareholder in Concordant Rater Systems and has served in the past year as a consultant for United Biosource Corporation, Clintara, Bracket, and Clinical Trials Network and Institute. Dr. Sylvia receives royalties from New Harbinger. She has received grant/research support from NIMH, PCORI, AFSP, and Takeda. 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 AHRQ. 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: Cleveland Foundation, NARSAD, and Stanley Medical Research Institute; he receives research grants from Abbott, AstraZeneca, Cephalon, GlaxoSmithKline, Janssen, Eli Lilly, 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. Dr. Deckersbach?s research has been funded by NIH, NIMH, NARSAD, TSA, IOCDF, Tufts University, DBDAT, Cogito, Sunovion, and Otsuka Pharmaceuticals. He has received honoraria, consultation fees and/or royalties from the MGH Psychiatry Academy, BrainCells Inc., Clintara, LLC, Systems Research and Applications Corporation, Boston University, the Catalan Agency for Health Technology Assessment and Research, the National Association of Social Workers Massachusetts, the Massachusetts Medical Society, Tufts University, NIDA, NIMH, Oxford University Press, Guilford Press, and Rutledge. He has also participated in research funded by DARPA, NIH, NIMH, NIA, AHRQ, PCORI, Janssen Pharmaceuticals, The Forest Research Institute, Shire Development Inc., Medtronic, Cyberonics, Northstar, and Takeda. Dr. Tohen was a full time employee at Lilly (1997 to 2008). He has received honoraria from, or consulted for, Abbott, AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Lilly, Johnson & Johnson, Otsuka, Merck, Sunovion, Forest, Geodon Richter Plc, Roche, Elan, Alkermes, Allergan, Lundbeck, Teva, Pamlab, Wyeth, and Wiley Publishing. His spouse was a full-time employee at Lilly (1998-2013). Dr. Bowden currently has no activities or consultant relationships to disclose. 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). He has received consulting income from the Qatar National Research Foundation and Merck Pharmaceuticals. Dr. Kocsis has received research grants and contracts from AHRQ, NIMH, NIDA, Burroughs Wellcome Trust, 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. Dr. Friedman 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. Dr. Friedman received grant support from NIMH, AHRQ, Novartis, St. Jude Medical, Medtronics, Repligen, AstraZeneca, Roche, and Takeda and Neosync. Between May 14, 2010 to present, Dr. Ketter had the following financial interests/arrangements or affiliations that could be perceived as real or apparent conflicts of interest: grant/research support from Agency for Healthcare Research and Quality, AstraZeneca Pharmaceuticals LP, Cephalon Inc. (now Teva Pharmaceuticals), Eli Lilly and Company, Pfizer, Inc., Merck & Co., Inc., and Sunovion Pharmaceuticals; consultant/advisory board fees from Acadia Pharmaceuticals, Allergan, Inc., Avanir Pharmaceuticals, Depotmed, Forest Pharmaceuticals, Genentech, Janssen Pharmaceuticals, Merck & Co., Inc., ProPhase, Sunovion Pharmaceuticals, Teva Pharmaceuticals, Bristol-Myers Squibb Company and Cephalon, Inc.; lecture honoraria from Abbott Laboratories, Inc., GlaxoSmithKline, Otsuka Pharmaceuticals, Pfizer, Inc., and AstraZeneca Pharmaceuticals LP; and royalties from American Psychiatric Publishing, Inc. In addition, Dr. Ketter's spouse is an employee of and holds stock in Janssen Pharmaceuticals. Dr. McElroy is a consultant to or member of the scientific advisory boards of Bracket, F. Hoffmann-La Roche Ltd., MedAvante, Naurex, Novo Nordisk, Shire, and Sunovion. She is a principal or co-investigator on studies sponsored by the Agency for Healthcare Research & Quality (AHRQ), Alkermes, Cephalon, Forest, Marriott Foundation, National Institute of Mental Health, Naurex, Orexigen Therapeutics, Inc., Shire, and Takeda Pharmaceutical Company Ltd. 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. Dr. Shelton has served as a consultant to Acadia Pharmaceuticals, Bristol-Myers Squibb, Cyberonics, Inc., Elan, Corp., Euthymics Bioscience, Cerecor Inc., Clintara LLC, Forest Pharmaceuticals, Janssen Pharmaceutica, Medtronic, Inc., MSI Methylation Sciences, Naurex, Inc., Nestle? Health Science -?Pamlab, Inc., Otsuka Pharmaceuticals, Pfizer, Inc., Ridge Diagnostics, Shire PLC, and Takeda Pharmaceuticals. Dr. Shelton has received research grant support from Appian Labs, Elan, Corp., Euthymics Bioscience, Forest Pharmaceuticals, Janssen Pharmaceutica, Naurex, Inc, Novartis Pharmaceuticals, Otsuka Pharmaceuticals,?Nestle??Health Science -?Pamlab, Inc., Repligen, Corp., Ridge Diagnostics, and Takeda Pharmaceuticals. Andrew A. Nierenberg is a consultant for the Abbott Laboratories, Alkermes, American Psychiatric Association, Appliance Computing Inc. (Mindsite), Basliea, Brain Cells, Inc., Brandeis University, Bristol Myers Squibb, Clintara, Corcept, Dey Pharmaceuticals, Dainippon Sumitomo (now Sunovion), Eli Lilly and Company, EpiQ, L.P./Mylan Inc., Forest, Genaissance, Genentech, GlaxoSmithKline, Hoffman LaRoche, Infomedic, Intra-Cellular Therapies, Lundbeck, Janssen Pharmaceutica, Jazz Pharmaceuticals, Medavante, Merck, Methylation Sciences, Naurex, NeuroRx, Novartis, Otsuka, PamLabs, Parexel, Pfizer, PGx Health, Ridge Diagnostics Shire, Schering-Plough, Somerset, Sunovion, Takeda Pharmaceuticals, Targacept, and Teva; consulted through the MGH Clinical Trials Network and Institute (CTNI) for Astra Zeneca, Brain Cells, Inc., Dianippon Sumitomo/Sepracor, Johnson and Johnson, Labopharm, Merck, Methylation Science, Novartis, PGx Health, Shire, Schering-Plough, Targacept, and Takeda/Lundbeck Pharmaceuticals. He receives grant/research support from American Foundation for Suicide Prevention, AHRQ, Brain and Behavior Research Foundation, Bristol-Myers Squibb, Cederroth, Cephalon, Cyberonics, Elan, Eli Lilly, Forest, GlaxoSmithKline, Janssen Pharmaceutica, Intra-Cellular Therapies, Lichtwer Pharma, Marriott Foundation, Mylan, NIMH, PamLabs, PCORI, Pfizer Pharmaceuticals, Shire, Stanley Foundation, Takeda, and Wyeth-Ayerst. Honoraria include Belvoir Publishing, University of Texas Southwestern Dallas, Brandeis University, Bristol-Myers Squibb, Hillside Hospital, American Drug Utilization Review, American Society for Clinical Psychopharmacology, Baystate Medical Center, Columbia University, CRICO, Dartmouth Medical School, Health New England, Harold Grinspoon Charitable Foundation, IMEDEX, Israel Society for Biological Psychiatry, Johns Hopkins University, MJ Consulting, New York State, Medscape, MBL Publishing, MGH Psychiatry Academy, National Association of Continuing Education, Physicians Postgraduate Press, SUNY Buffalo, University of Wisconsin, University of Pisa, University of Michigan, University of Miami, University of Wisconsin at Madison, World Congress of Brain Behavior and Emotion, APSARD, ISBD, SciMed, Slack Publishing and Wolters Klower Publishing ASCP, NCDEU, Rush Medical College, Yale University School of Medicine, NNDC, Nova Southeastern University, NAMI, Institute of Medicine, CME Institute, and ISCTM. He was currently or formerly on the advisory boards of Appliance Computing, Inc., Brain Cells, Inc., Eli Lilly and Company, Genentech, Johnson and Johnson, Takeda/Lundbeck, Targacept, and InfoMedic. He owns stock options in Appliance Computing, Inc., Brain Cells, Inc., and Medavante; has copyrights to the Clinical Positive Affect Scale and the MGH Structured Clinical Interview for the Montgomery Asberg Depression Scale exclusively licensed to the MGH Clinical Trials Network and Institute (CTNI). Publisher Copyright: © 2017 Wiley Periodicals, Inc.
PY - 2017/3/1
Y1 - 2017/3/1
N2 - Background: Many mood disorder patients need analgesics due to increased pain sensitivity. Recent studies have suggested that nonsteroidal anti-inflammatory drugs (NSAIDs) may inhibit antidepressant treatment, which requires replication before clinical recommendations. Methods: The Clinical and Health Outcomes Initiatives in Comparative Effectiveness for Bipolar Disorder Study randomized participants to 6 months lithium or quetiapine treatment. Use of NSAIDs and paracetamol was assessed throughout the study period and psychopathology measured with the Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) and Bipolar Inventory of Symptoms Scale (BISS). The effects of NSAIDs and paracetamol on treatment outcome were examined using mixed effects linear regression adjusted for age, gender, body mass index, smoking status, exercise, and somatic diseases. Results: Among 482 participants, 177 (36.7%) used NSAIDs and/or paracetamol during the study. NSAID and paracetamol users did not differ from nonusers with respect to treatment outcome with lithium or quetiapine at any time point during 6 months treatment on the overall CGI-BP (β = 0.001 (95% CI = −0.01 to −0.01), P =.87), the BISS (β = 0.01 (95% CI = −0.17 to 0.15), P =.91), nor the CGI-BP subscales for depression or mania. Users of NSAIDs only (n = 76), paracetamol only (n = 62), and users of both NSAIDs and paracetamol (n = 39) showed no statistical difference compared to nonusers (all P >.3). Conclusions: This is the first trial to show that use of NSAIDs and paracetamol, alone or in combination, does not affect lithium- or quetiapine-based bipolar disorder mood-stabilizing treatment outcomes. Prior studies have suggested that NSAIDs may inhibit antidepressant treatment, whereas our results support findings indicating no detrimental effects of NSAIDs or paracetamol on affective disorder treatment.
AB - Background: Many mood disorder patients need analgesics due to increased pain sensitivity. Recent studies have suggested that nonsteroidal anti-inflammatory drugs (NSAIDs) may inhibit antidepressant treatment, which requires replication before clinical recommendations. Methods: The Clinical and Health Outcomes Initiatives in Comparative Effectiveness for Bipolar Disorder Study randomized participants to 6 months lithium or quetiapine treatment. Use of NSAIDs and paracetamol was assessed throughout the study period and psychopathology measured with the Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) and Bipolar Inventory of Symptoms Scale (BISS). The effects of NSAIDs and paracetamol on treatment outcome were examined using mixed effects linear regression adjusted for age, gender, body mass index, smoking status, exercise, and somatic diseases. Results: Among 482 participants, 177 (36.7%) used NSAIDs and/or paracetamol during the study. NSAID and paracetamol users did not differ from nonusers with respect to treatment outcome with lithium or quetiapine at any time point during 6 months treatment on the overall CGI-BP (β = 0.001 (95% CI = −0.01 to −0.01), P =.87), the BISS (β = 0.01 (95% CI = −0.17 to 0.15), P =.91), nor the CGI-BP subscales for depression or mania. Users of NSAIDs only (n = 76), paracetamol only (n = 62), and users of both NSAIDs and paracetamol (n = 39) showed no statistical difference compared to nonusers (all P >.3). Conclusions: This is the first trial to show that use of NSAIDs and paracetamol, alone or in combination, does not affect lithium- or quetiapine-based bipolar disorder mood-stabilizing treatment outcomes. Prior studies have suggested that NSAIDs may inhibit antidepressant treatment, whereas our results support findings indicating no detrimental effects of NSAIDs or paracetamol on affective disorder treatment.
KW - bipolar disorder
KW - lithium
KW - nonsteroidal anti-inflammatory drugs (NSAIDs)
KW - paracetamol
KW - polypharmacy
KW - quetiapine
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U2 - 10.1002/da.22601
DO - 10.1002/da.22601
M3 - Article
C2 - 28135023
AN - SCOPUS:85011554808
VL - 34
SP - 281
EP - 290
JO - Anxiety
JF - Anxiety
SN - 1091-4269
IS - 3
ER -