Abstract
Objective: An antidepressant medication switch often follows a failed initial trial with selective serotonin reuptake inhibitors (SSRIs). When, for whom, and how often second-step response and remission occur are unclear, as is preferred second-step trial duration. As more treatments are approved for use following 2 failed “adequate” trials, researchers and clinicians require an evidence-based definition of “adequate.” Methods: Following citalopram in the randomized Sequenced Treatment Alternatives to Relieve Depression (STAR*D) clinical trial (which ran July 2001-September 2006), participants with score ≥ 11 on the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated (QIDS-SR16) were randomized to bupropion sustained release, sertraline, or venlafaxine extended release (up to 14 weeks). The QIDS-SR16 defined response, remission, and no clinically meaningful benefit based on the modified intent-to-treat sample. Results: About 80% of 438 participants completed ≥ 6 weeks of treatment with the switch medication. All treatments had comparable outcomes. Overall, 21% (91/438) remitted, 9% (40/438) responded without remission, and 58% (255/438) had no meaningful benefit. Half of the responses and two-thirds of remissions occurred after 6 weeks of treatment. Overall, 33% of responses (43/131) occurred after ≥ 9 weeks of treatment. No baseline features differentiated early from later responders or remitters. No early triage point was found, but those with at least 20% reduction from baseline in QIDS-SR16 score around week 2 were 6 times more likely to respond or remit than those without this reduction. Conclusions: Following nonefficacy with an initial SSRI, only about 20% remit and more than half achieve no meaningful benefit with a second-step switch to another monoaminergic antidepressant. A 12-week trial duration seems necessary to capture as many second-step switch responders as possible.
Original language | English (US) |
---|---|
Article number | 19M12949 |
Journal | Journal of Clinical Psychiatry |
Volume | 81 |
Issue number | 5 |
DOIs | |
State | Published - Oct 2020 |
ASJC Scopus subject areas
- Psychiatry and Mental health
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In: Journal of Clinical Psychiatry, Vol. 81, No. 5, 19M12949, 10.2020.
Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - What to Expect When Switching to a Second Antidepressant Medication Following an Ineffective Initial SSRI
T2 - A Report From the Randomized Clinical STAR*D Study
AU - Rush, A. John
AU - South, Charles
AU - Jha, Manish K.
AU - Jain, Shailesh Bobby
AU - Trivedi, Madhukar H.
N1 - Funding Information: Submitted:June10,2019; accepted March 20, 2020. 2. Rush AJ,Trivedi MH, Wisniewski SR, et al. Acute burden of side effects. J Psychiatr Pract. Publishedonline:August11,2020. and longer-term outcomes in depressed 2006;12(2):71–79.PubMed CrossRef Potential conflicts of interest:DrRushhas outpatients requiring one or several treatment 15. Rush AJ, Thase ME. Improving depression received consulting fees from Akili, Brain Resource, steps: a STAR*D report. Am J Psychiatry. outcome by patient-centered medical Compass, Curbstone Consultant, Emmes, Holmusk, 2006;163(11):1905–1917.PubMed CrossRef management. Am J Psychiatry. Johnson & Johnson (Janssen), and Liva-Nova; 3. Rush AJ, Jain S. Clinical implications of the 2018;175(12):1187–1198.PubMed CrossRef STAR*D Trial. In: Handbook of Experimental Rush AJ. Isn’t it about time to employ speaking fees from Liva-Nova; and royalties Pharmacology. Berlin, Germany: Springer; measurement-based care in practice? Am J from Guilford Press and the University ofTexas 2018. Psychiatry. 2015;172(10):934–936.PubMed CrossRef Southwestern Medical Center,Dallas,Texas (for 4. Wisniewski SR, Fava M, Trivedi MH, et al. Rush AJ, Crismon ML, Kashner TM, et al; TMAP the Inventory of Depressive Symptoms and its Acceptability of second-step treatments to Research Group. Texas Medication Algorithm derivatives) and is named co-inventor on 2 patents: depressed outpatients: a STAR*D report. Am J Project, phase 3 (TMAP-3): rationale and study US Patent No.7,795,033: Methods to Predict the Psychiatry. 2007;164(5):753–760.PubMed CrossRef design. J Clin Psychiatry. 2003;64(4):357–369.PubMed CrossRef Outcome ofTreatment with Antidepressant 5. Rush AJ, Trivedi MH, Wisniewski SR, et al; Bauer M, Rush AJ, Ricken R, et al. Algorithms for Medication; Inventors: McMahonFJ, Laje G, Manji H, STAR*D Study Team. Bupropion-SR, sertraline, treatment of major depressive disorder: Rush AJ, Paddock S, Wilson AS; and US Patent No. or venlafaxine-XR after failure of SSRIs for efficacy and cost-effectiveness. 7,906,283: Methods to Identify Patients at Risk of depression. N Engl J Med. Pharmacopsychiatry. 2019;52(3):117–125.PubMed Developing Adverse Events DuringTreatment with 2006;354(12):1231–1242.PubMed CrossRef Guo T, Xiang Y-T, Xiao L, et al. Measurement-AntidepressantMedication;Inventors:McMahon 6. Rush AJ, Fava M, Wisniewski SR, et al; STAR*D based care versus standard care for major FJ, Laje G, Manji H, Rush AJ, Paddock S. Dr Jhahas Investigators Group. Sequenced treatment depression: a randomized controlled trial with received contract research grants from Acadia alternatives to relieve depression (STAR*D): blind raters. Am J Psychiatry. and Janssen Research & Development. DrTrivedi rationale and design. Control Clin Trials. 2015;172(10):1004–1013.PubMed CrossRef has received research support from the National 2004;25(1):119–142.PubMed CrossRef Krägeloh CU, Czuba KJ, Billington DR, et al. Funding Information: Institute of Mental Health (NIMH), the National 7. Lavori PW, Rush AJ, Wisniewski SR, et al. Using feedback from patient-reported Institute on Drug Abuse, Johnson & Johnson, Strengthening clinical effectiveness trials: outcome measures in mental health services: a and Janssen Research & Development and has equipoise-stratified randomization. Biol scoping study and typology. Psychiatr Serv. served as a consultant for Alkermes, Allergan, Psychiatry. 2001;50(10):792–801.PubMed CrossRef 2015;66(3):224–241.PubMed CrossRef Arcadia,AstraZeneca,Lundbeck,Medscape,MSI 8. Fava M, Rush AJ, Trivedi MH, et al. Background Trivedi MH, Fava M, Wisniewski SR, et al; Methylation Sciences, Merck, Otsuka America, and and rationale for the sequenced treatment STAR*D Study Team. Medication augmentation Takeda.DrsSouthand Jainhave no conflicts of alternatives to relieve depression (STAR*D) after the failure of SSRIs for depression. N Engl J interesttoreport. study. Psychiatr Clin North Am. Med. 2006;354(12):1243–1252.PubMed CrossRef Funding/support:This work was supported by 2003;26(2):457–494, x.PubMed CrossRef Hamilton M. Development of a rating scale for NIMH, which funded the SequencedTreatment 9. Nierenberg AA, Keefe BR, Leslie VC, et al. primary depressive illness. Br J Soc Clin Psychol. AlternativestoRelieveDepression(STAR*D) trial Residual symptoms in depressed patients who 1967;6(4):278–296.PubMed CrossRef (grant no. N01MH-90003). The authors wish to respond acutely to fluoxetine. J Clin Psychiatry. Conway CR, Kumar A, Xiong W, et al. Chronic recognize the contributions of Bristol-Myers 1999;60(4):221–225.PubMed CrossRef vagus nerve stimulation significantly improves Squibb, Forest Pharmaceuticals, GlaxoSmithKline, 10. Trivedi MH, Rush AJ, Gaynes BN, et al. quality of life in treatment-resistant major King Pharmaceuticals, Organon, Pfizer,and Wyeth- Maximizing the adequacy of medication depression. J Clin Psychiatry. Ayerst Laboratories, which provided medications at treatment in controlled trials and clinical 2018;79(5):18m12178.PubMed CrossRef no cost for the STAR*Dtrial. practice: STAR(*)D measurement-based care. Zimmerman M, Mattia JI. The Psychiatric Role of the sponsor: The aforementioned Neuropsychopharmacology. Diagnostic Screening Questionnaire: supporters had no role in the design, conduct, data 2007;32(12):2479–2489.PubMed CrossRef development, reliability and validity. Compr analysis, interpretation, drafting of the manuscript, Rush AJ, Trivedi MH, Ibrahim HM, et al. The Psychiatry. 2001;42(3):175–189.PubMed CrossRef or publication of the study results. 16-Item Quick Inventory of Depressive Rush AJ, Zimmerman M, Wisniewski SR, et al. Acknowledgments:The authors would like to Symptomatology (QIDS), clinician rating Comorbid psychiatric disorders in depressed thank Corrie Brown, BAAS, (self-employed) for (QIDS-C), and self-report (QIDS-SR): a outpatients: demographic and clinical features. hersecretarialandadministrativesupport;Jon psychometric evaluation in patients with J Affect Disord. 2005;87(1):43–55.PubMed CrossRef Kilner,MS, MA, ofhis self-named medical/scientific chronic major depression. Biol Psychiatry. Ware J Jr, Kosinski M, Keller SD. A 12-Item editing service for his medical editing support 2003;54(5):573–583.PubMed CrossRef Short-Form Health Survey: construction of (sehala@zoominternet.net);andGeorganna 12. Inventory of Depressive Symptomatology (IDS) scales and preliminary tests of reliability and Carlock, BA, ofthe Center for Depression Research and Quick Inventory of Depressive validity.MedCare. 1996;34(3):220–233.PubMedCrossRef and Clinical Care for editorial support. These Symptomatology. (QIDS): About the IDS and Reilly MC, Zbrozek AS, Dukes EM. The validity persons have no conflicts of interest to declare. QIDS. IDS/QIDS Web site. http://www.ids-qids. and reproducibility of a work productivity and org/index.html. Updated 2019. Accessed activity impairment instrument. Supplementarymaterial:Available at March 11, 2019. Pharmacoeconomics. 1993;4(5):353–365.PubMed CrossRef PSYCHIATRIST.COM. 13. Rush AJ. Quick Inventory of Depressive Mundt JC, Marks IM, Shear MK, et al. The Work Symptomatology (QIDS-SR and QIDS-C). and Social Adjustment Scale: a simple measure ePROVIDE, Mapi Research Trust Web site. of impairment in functioning. Br J Psychiatry. https://eprovide.mapi-trust.org/instruments/ 2002;180(5):461–464.PubMed CrossRef 1. Trivedi MH, Rush AJ, Wisniewski SR, et al; quick-inventory-of-depressive-R: A Language and Environment for Statistical STAR*D Study Team. Evaluation of outcomes symptomatology. Updated March 2019. Computing. Vienna, Austria: R Foundation for with citalopram for depression using Accessed March 22, 2019. Statistical Computing; 2013;3(1):201. measurement-based care in STAR*D: Wisniewski SR, Rush AJ, Balasubramani GK, et R Core Team. R: A language and environment implications for clinical practice. Am J al; STAR*D Investigators. Self-rated global for statistical computing. R Foundation for Psychiatry. 2006;163(1):28–40.PubMed CrossRef measure of the frequency, intensity, and Statistical Computing; Vienna, Austria. https:// Publisher Copyright: © Copyright 2020 Physicians Postgraduate Press, Inc.
PY - 2020/10
Y1 - 2020/10
N2 - Objective: An antidepressant medication switch often follows a failed initial trial with selective serotonin reuptake inhibitors (SSRIs). When, for whom, and how often second-step response and remission occur are unclear, as is preferred second-step trial duration. As more treatments are approved for use following 2 failed “adequate” trials, researchers and clinicians require an evidence-based definition of “adequate.” Methods: Following citalopram in the randomized Sequenced Treatment Alternatives to Relieve Depression (STAR*D) clinical trial (which ran July 2001-September 2006), participants with score ≥ 11 on the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated (QIDS-SR16) were randomized to bupropion sustained release, sertraline, or venlafaxine extended release (up to 14 weeks). The QIDS-SR16 defined response, remission, and no clinically meaningful benefit based on the modified intent-to-treat sample. Results: About 80% of 438 participants completed ≥ 6 weeks of treatment with the switch medication. All treatments had comparable outcomes. Overall, 21% (91/438) remitted, 9% (40/438) responded without remission, and 58% (255/438) had no meaningful benefit. Half of the responses and two-thirds of remissions occurred after 6 weeks of treatment. Overall, 33% of responses (43/131) occurred after ≥ 9 weeks of treatment. No baseline features differentiated early from later responders or remitters. No early triage point was found, but those with at least 20% reduction from baseline in QIDS-SR16 score around week 2 were 6 times more likely to respond or remit than those without this reduction. Conclusions: Following nonefficacy with an initial SSRI, only about 20% remit and more than half achieve no meaningful benefit with a second-step switch to another monoaminergic antidepressant. A 12-week trial duration seems necessary to capture as many second-step switch responders as possible.
AB - Objective: An antidepressant medication switch often follows a failed initial trial with selective serotonin reuptake inhibitors (SSRIs). When, for whom, and how often second-step response and remission occur are unclear, as is preferred second-step trial duration. As more treatments are approved for use following 2 failed “adequate” trials, researchers and clinicians require an evidence-based definition of “adequate.” Methods: Following citalopram in the randomized Sequenced Treatment Alternatives to Relieve Depression (STAR*D) clinical trial (which ran July 2001-September 2006), participants with score ≥ 11 on the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated (QIDS-SR16) were randomized to bupropion sustained release, sertraline, or venlafaxine extended release (up to 14 weeks). The QIDS-SR16 defined response, remission, and no clinically meaningful benefit based on the modified intent-to-treat sample. Results: About 80% of 438 participants completed ≥ 6 weeks of treatment with the switch medication. All treatments had comparable outcomes. Overall, 21% (91/438) remitted, 9% (40/438) responded without remission, and 58% (255/438) had no meaningful benefit. Half of the responses and two-thirds of remissions occurred after 6 weeks of treatment. Overall, 33% of responses (43/131) occurred after ≥ 9 weeks of treatment. No baseline features differentiated early from later responders or remitters. No early triage point was found, but those with at least 20% reduction from baseline in QIDS-SR16 score around week 2 were 6 times more likely to respond or remit than those without this reduction. Conclusions: Following nonefficacy with an initial SSRI, only about 20% remit and more than half achieve no meaningful benefit with a second-step switch to another monoaminergic antidepressant. A 12-week trial duration seems necessary to capture as many second-step switch responders as possible.
UR - http://www.scopus.com/inward/record.url?scp=85089359864&partnerID=8YFLogxK
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U2 - 10.4088/JCP.19M12949
DO - 10.4088/JCP.19M12949
M3 - Article
C2 - 32780949
AN - SCOPUS:85089359864
SN - 0160-6689
VL - 81
JO - Journal of Clinical Psychiatry
JF - Journal of Clinical Psychiatry
IS - 5
M1 - 19M12949
ER -