Effectiveness and Feasibility of a Standardized Stepwise Drug Treatment Regimen Algorithm for Inpatients With Depressive Disorders

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Abstract
The goal of the Berlin Algorithm Project is to establish a standardized stepwise drug treatment regimen (SSTR) for the treatment of inpatients with depressive disorders. We are reporting on the first of 3 subsequent study phases evaluating effectiveness and feasibility of the SSTR in a naturalistic clinical setting. Patients with depressive disorders (International Classification of Diseases, Ninth Revision criteria) admitted to an academic medical center for inpatient treatment were enrolled in the SSTR protocol that comprised an algorithm-guided sequential treatment process (including pharmacologic washout period, sleep deprivation, antidepressant monotherapy, lithium augmentation, monoamine oxidase inhibitor treatment, and electroconvulsive therapy) dependent on the scores of a standardized assessment of treatment outcome, the Bech Rafaelsen Melancholia Scale (BRMS). Of 248 patients with depression, 119 (48%) were enrolled in the SSTR protocol. One hundred twenty-nine patients (52%) were not included, mostly due to individualized treatment procedures. An intent-to-treat (ITT) analysis showed that 38% of enrolled patients achieved remission (BRMS score < or = 5), 34% achieved "classic" response (deltaBRMS score > or = 50%), 15% achieved "low" response (deltaBRMS score 26% to 49%), and 13% did not respond. The overall response rate (remitters and classic responders) of SSTR treatment was 72% of the ITT sample. Twenty-one patients (18%) dropped out from the SSTR as nonresponders and 19 patients (16%) dropped out as low responders due to protocol deviations. The acceptance of the antidepressive treatment algorithm among physicians not specifically trained was moderate, resulting in a relatively low enrollment rate. However, once patients were enrolled into the study, adherence to the algorithm-based rules resulted in a low dropout rate. Most importantly, algorithm-guided antidepressive treatment showed a favorable response in those depressed patients who were treated according to the SSTR protocol.

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