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

NCT02191124 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2014-07-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Paroxetine

Patients in both groups (MBC or ST) receive open-label paroxetine (20-60mg/day) within the therapeutic dose range recommended by the Guidelines for the Prevention and Treatment of Major Depression in China.

DRUG

Mirtazapine

Patients in both groups (MBC or ST) receive open-label mirtazapine (15-45mg/day) within the therapeutic dose range recommended by the Guidelines for the Prevention and Treatment of Major Depression in China

Sponsors & Collaborators

  • Capital Medical University

    lead OTHER

Principal Investigators

  • Gang Wang, MD;PhD · Beijing Anding Hospital, Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02191124 on ClinicalTrials.gov