Tong Guo1, Yu-Tao Xiang1, Le Xiao1, Chang-Qing Hu1, Helen F K Chiu1, Gabor S Ungvari1, Christoph U Correll1, Kelly Y C Lai1, Lei Feng1, Ying Geng1, Yuan Feng1, Gang Wang1. 1. From the Mood Disorders Center and Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing; the Center of Depression, Beijing Institute for Brain Disorders and China Clinical Research Center for Mental Disorders, Beijing; the Unit of Psychiatry, Faculty of Health Sciences, University of Macau; the Department of Psychiatry, Chinese University of Hong Kong, Hong Kong; the University of Notre Dame Australia, Marian Centre, Perth; the School of Psychiatry and Clinical Neurosciences, University of Western Australia, Perth; and the Division of Psychiatry Research, Zucker Hillside Hospital, North Shore-Long Island Jewish Health System, Glen Oaks, N.Y.
Abstract
OBJECTIVE: The authors compared measurement-based care with standard treatment in major depression. METHODS:Outpatients with moderate to severe major depression were consecutively randomized to 24 weeks of either measurement-based care (guideline- and rating scale-based decisions; N=61), or standard treatment (clinicians' choice decisions; N=59). Pharmacotherapy was restricted to paroxetine (20-60 mg/day) or mirtazapine (15-45 mg/day) in both groups. Depressive symptoms were measured with the Hamilton Depression Rating Scale (HAM-D) and the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR). Time to response (a decrease of at least 50% in HAM-D score) and remission (a HAM-D score of 7 or less) were the primary endpoints. Outcomes were evaluated by raters blind to study protocol and treatment. RESULTS: Significantly more patients in the measurement-based care group than in the standard treatment group achieved response (86.9% compared with 62.7%) and remission (73.8% compared with 28.8%). Similarly, time to response and remission were significantly shorter with measurement-based care (for response, 5.6 weeks compared with 11.6 weeks, and for remission, 10.2 weeks compared with 19.2 weeks). HAM-D scores decreased significantly in both groups, but the reduction was significantly larger for the measurement-based care group (-17.8 compared with -13.6). The measurement-based care group had significantly more treatment adjustments (44 compared with 23) and higher antidepressant dosages from week 2 to week 24. Rates of study discontinuation, adverse effects, and concomitant medications did not differ between groups. CONCLUSIONS: The results demonstrate the feasibility and effectiveness of measurement-based care for outpatients with moderate to severe major depression, suggesting that this approach can be incorporated in the clinical care of patients with major depression.
RCT Entities:
OBJECTIVE: The authors compared measurement-based care with standard treatment in major depression. METHODS: Outpatients with moderate to severe major depression were consecutively randomized to 24 weeks of either measurement-based care (guideline- and rating scale-based decisions; N=61), or standard treatment (clinicians' choice decisions; N=59). Pharmacotherapy was restricted to paroxetine (20-60 mg/day) or mirtazapine (15-45 mg/day) in both groups. Depressive symptoms were measured with the Hamilton Depression Rating Scale (HAM-D) and the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR). Time to response (a decrease of at least 50% in HAM-D score) and remission (a HAM-D score of 7 or less) were the primary endpoints. Outcomes were evaluated by raters blind to study protocol and treatment. RESULTS: Significantly more patients in the measurement-based care group than in the standard treatment group achieved response (86.9% compared with 62.7%) and remission (73.8% compared with 28.8%). Similarly, time to response and remission were significantly shorter with measurement-based care (for response, 5.6 weeks compared with 11.6 weeks, and for remission, 10.2 weeks compared with 19.2 weeks). HAM-D scores decreased significantly in both groups, but the reduction was significantly larger for the measurement-based care group (-17.8 compared with -13.6). The measurement-based care group had significantly more treatment adjustments (44 compared with 23) and higher antidepressant dosages from week 2 to week 24. Rates of study discontinuation, adverse effects, and concomitant medications did not differ between groups. CONCLUSIONS: The results demonstrate the feasibility and effectiveness of measurement-based care for outpatients with moderate to severe major depression, suggesting that this approach can be incorporated in the clinical care of patients with major depression.
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