drugset / Trial / NCT02191124

The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial

NCT02191124

Phase 4 Completed 164 enrolled Capital Medical University
RandomizedFactorialDouble-blindTreatment

Summary

In recent years, measurement-based care (MBC) has been gaining more attention in the treatment of depression because it allows psychiatrists to individualize treatment decisions for each patient based on the change of psychopathology and tolerance toward antidepressants. Several studies, such as the Sequenced Treatment Alternatives to Relieve Depression (STAR\*D) trial using MBC, found that MBC-informed sequential algorithms can be successfully integrated into clinical practice and improve patients' outcomes However, despite a strong theoretical rationale for MBC and data supporting the ability to implement MBC in clinical practice settings, there is currently no randomized controlled trial in MDD patients comparing MBC with usual/standard care. The investigators compare MBC with clinician's treatment decisions, standardizing care to two commonly prescribed antidepressants. Therefore, the aim of this study is to determine the effects of MBC in patients with MDD compared to standard treatment (ST). The research hypothesis is that compared to ST, the estimated time to response and to remission would be significantly shorter in the MBC group without increased dropout rates and side effect burden.

Timeline

Start
2011-06
Primary completion
2012-11
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Mirtazapine Other / unclassified 45 mg
Subject Paroxetine Small molecule 60 mg