Measurement-Based Care Versus Standard Care for Major Depression: A Randomized Controlled Trial With Blind Raters.

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.