Symptomatic and Functional Outcomes and Early Prediction of Response to Escitalopram Monotherapy and Sequential Adjunctive Aripiprazole Therapy in Patients With Major Depressive Disorder: A CAN-BIND-1 Report.
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Kennedy Sidney H, Lam Raymond W, Rotzinger Susan, Milev Roumen V, Blier Pierre, Downar Jonathan, Evans Kenneth R, Farzan Faranak, Foster Jane A, Frey Benicio N, Giacobbe Peter, Hall Geoffrey B, Harkness Kate L, Hassel Stefanie, Ismail Zahinoor, Leri Francesco, McInerney Shane, MacQueen Glenda M, Minuzzi Luciano, Müller Daniel J, Parikh Sagar V, Placenza Franca M, Quilty Lena C, Ravindran Arun V, Sassi Roberto B, Soares Claudio N, Strother Stephen C, Turecki Gustavo, Vaccarino Anthony L, Vila-Rodriguez Fidel, Yu Joanna, Uher Rudolf, CAN-BIND Investigator Team
Аннотация
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.