The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Objective: To compare the effectiveness and feasibility of the measurement-based care (MBC)
      in the treatment of depression with clinician's treatment decisions, standardizing treatment
      (ST, clinicians' choice decisions) to two commonly prescribed antidepressants.

      Methods: Selecting the patients in psychiatric hospitals and general hospitals with
      depression, with multi-center randomized controlled study design. Refer to STAR-D
      "measurement-based care" mode, to establish the whole measurement-based evaluation system.
      Eligible patients will be randomly assigned to 24 weeks of MBC or ST, restricting treatment
      to paroxetine (20-60mg/day) or mirtazapine (15-45mg/day) in both groups. the ST group will
      maximize simulate of the actual clinical situation, and the patients of the MBC group are
      required to complete the prospective Life-chart Methodology (LCM-p), 16-item Quick Inventory
      of Depressive Symptomatology Self-Report (QIDS-SR16) and other related symptoms and side
      effects of self-assessment, the doctor will make a comprehensive assessment according to the
      results of self-assessment, adjust treatment according to research programs. This is 1-year
      follow-up study; the independent members will have a blinded assessment in the baseline visit
      and each point of view. Depressive symptoms are measured using the Hamilton Rating Scale for
      Depression (HAMD) and QIDS-SR.
    

Intervention name(s): Paroxetine; Mirtazapine
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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
Other intervention name(s): Seroxat; Remeron
Intervention MeSH terms: Mirtazapine; Paroxetine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Measurement-based care; Unipolar depression; Outpatients