Objective: To report the symptomatic and functional outcomes in patients with major depressive disorder (MDD) during a 2-phase treatment trial and to estimate the value of early improvement after 2 weeks in predicting clinical response to escitalopram and subsequently to adjunctive treatment with aripiprazole.
Methods: Participants with MDD (N = 211) identified with the Montgomery-Asberg Depression Rating Scale (MADRS) and confirmed with the Mini-International Neuropsychiatric Interview were recruited from 6 outpatient centers across Canada (August 2013 through December 2016) and treated with open-label escitalopram (10-20 mg) for 8 weeks (Phase 1). Clinical and functional outcomes were evaluated using the MADRS, Quick Inventory of Depressive Symptomatology-Self-Rated (QIDS-SR), Sheehan Disability Scale (SDS), and Lam Employment Absence and Productivity Scale (LEAPS). Participants were evaluated at 8 and 16 weeks for clinical and functional response and remission. Phase 1 responders continued escitalopram while nonresponders received adjunctive aripiprazole (2-10 mg) for a further 8 weeks (Phase 2).
Results: After Phase 1, MADRS response (≥ 50% decrease from baseline) and remission (score ≤ 10) were, respectively, 47% and 31%, and SDS response (score ≤ 12) and remission (score ≤ 6) were, respectively, 53% and 24%. Response to escitalopram was maintained in 91% of participants at week 16, while 61% of the adjunctive aripiprazole group achieved MADRS response during Phase 2. Response and remission rates with the QIDS-SR were lower than with the MADRS. The LEAPS demonstrated significant occupational improvement (P < .05). Early symptomatic improvement predicted outcomes with modest accuracy.
Conclusions: This study demonstrates comparable symptomatic and functional outcomes to those of other large practical-design studies. There was a high response rate with the adjunctive use of aripiprazole in escitalopram nonresponders. Given the limited value of early clinical improvement to predict outcome, integration of clinical and biological markers deserves further exploration.
Trial Registration: ClinicalTrials.gov identifier: NCT01655706
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About the Authors
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Raymond W. Lam, MDUniversity of British Columbia and Vancouver Coastal Health Authority, Vancouver, British Columbia, CanadaView full profile
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Pierre Blier, MD, PhDUniversity of Ottawa Institute of Mental Health Research, Ottawa, Ontario, CanadaView full profile
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Sidney H. Kennedy, MDDepartment of Psychiatry, Krembil Research Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Keenan Research Centre for Biomedical Science, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada; Corresponding author: Sidney H. Kennedy, MD, St Michael's Hospital, 193 Yonge St, Ste 6-001A, Toronto, ON M5B1M4, Canada ([email protected])View full profile
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Glenda M. MacQueen, MD, PhDUniversity of Calgary, Hotchkiss Brain Institute, Calgary, Alberta, CanadaView full profile
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Claudio N. Soares, MD, PhD, MBADepartment of Psychiatry, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, Queen's University and Providence Care Hospital, Kingston, Ontario, CanadaView full profile
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Anthony L. Vaccarino, PhDIndoc Research, Toronto, Ontario, CanadaView full profile
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Rudolf Uher, MD, PhDDepartment of Psychiatry, Dalhousie University, Halifax, Nova Scotia, CanadaView full profile
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Sagar V. Parikh, MDUniversity of Michigan, Ann Arbor, MichiganView full profile
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Gustavo Turecki, MD, PhDMcGill University, Montréal, Quebec, Canada; Douglas Mental Health University Institute Frank B. Common (FBC), Montréal, Quebec, CanadaView full profile
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Susan Rotzinger, PhDDepartment of Psychiatry, Krembil Research Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, CanadaView full profile
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Roumen V. Milev, MD, PhDDepartment of Psychiatry, Queen's University and Providence Care Hospital, Kingston, Ontario, Canada; Department of Psychology, Queen's University, Kingston, Ontario, CanadaView full profile
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Jonathan Downar, MD, PhDDepartment of Psychiatry, Krembil Research Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, CanadaView full profile
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Kenneth R. Evans, PhDIndoc Research, Toronto, Ontario, Canada; Department of Pathology and Molecular Medicine, Queen’s University, Kingston, Ontario, CanadaView full profile
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Faranak Farzan, PhDDepartment of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Centre for Addiction and Mental Health, Toronto, Ontario, CanadaView full profile
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Jane A. Foster, PhDDepartment of Psychiatry, Krembil Research Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry and Behavioural Neurosciences, McMaster University, and St Joseph's Healthcare Hamilton, Hamilton, Ontario, CanadaView full profile
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Benicio N. Frey, MD, PhDDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, and St Joseph's Healthcare Hamilton, Hamilton, Ontario, CanadaView full profile
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Peter Giacobbe, MDDepartment of Psychiatry, Krembil Research Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, CanadaView full profile
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Geoffrey B. Hall, PhDDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, and St Joseph's Healthcare Hamilton, Hamilton, Ontario, CanadaView full profile
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Kate L. Harkness, PhDDepartment of Psychology, Queen's University, Kingston, Ontario, CanadaView full profile
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Stefanie Hassel, PhDUniversity of Calgary, Hotchkiss Brain Institute, Calgary, Alberta, CanadaView full profile
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Zahinoor Ismail, MDUniversity of Calgary, Hotchkiss Brain Institute, Calgary, Alberta, CanadaView full profile
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Francesco Leri, PhDUniversity of Guelph, Guelph, Ontario, CanadaView full profile
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Arun V. Ravindran, MD, PhDDepartment of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Centre for Addiction and Mental Health, Toronto, Ontario, CanadaView full profile
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Shane McInerney, MDDepartment of Psychiatry, Krembil Research Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, St Michael's Hospital, University of Toronto, Toronto, Ontario, CanadaView full profile
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Luciano Minuzzi, MD, PhDDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, and St Joseph's Healthcare Hamilton, Hamilton, Ontario, CanadaView full profile
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Daniel J. Müller, MD, PhDDepartment of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Centre for Addiction and Mental Health, Toronto, Ontario, CanadaView full profile
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Franca M. Placenza, PhDDepartment of Psychiatry, Krembil Research Centre, University Health Network, University of Toronto, Toronto, Ontario, CanadaView full profile
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Lena C. Quilty, PhDDepartment of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Centre for Addiction and Mental Health, Toronto, Ontario, CanadaView full profile
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Roberto B. Sassi, MD, PhDDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, and St Joseph's Healthcare Hamilton, Hamilton, Ontario, CanadaView full profile
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Stephen C. Strother, PhDRotman Research Institute at Baycrest Centre, Toronto, Ontario, CanadaView full profile
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Fidel Vila-Rodriguez, MDUniversity of British Columbia and Vancouver Coastal Health Authority, Vancouver, British Columbia, CanadaView full profile
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Joanna Yu, PhDDepartment of Psychiatry, St Michael's Hospital, University of Toronto, Toronto, Ontario, CanadaView full profile
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CAN-BIND Investigator TeamMembers of the CAN-BIND Investigator Team are listed at www.canbind.ca/our-team/View full profile
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