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NCT Number: NCT02191124

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Anding Hospital

Beijing, Beijing Municipality, 100088, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-65 years;
  • outpatients;
  • diagnosis of non-psychotic MDD established by treating psychiatrists and confirmed by a checklist based on DSM-IV criteria at study entry ;
  • total score of HAMD-17≥17;
  • ability to communicate and provide written consent.

Exclusion criteria

  • current or past history of drug and alcohol dependence, bipolar, psychotic, obsessive-compulsive, or eating disorders;
  • history of lack of response or intolerance to any of the two protocol antidepressants (paroxetine or mirtazapine);
  • being pregnant or breast-feeding;
  • suicide attempts in the current depressive episode or major medical conditions contraindicating the use of the protocol antidepressants.

Treatment and study plan

paroxetine

Drug

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.

Other names: Seroxat

mirtazapine

Drug

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 names: Remeron

Primary outcomes

  1. The estimated time from randomization to response and remission according to Hamilton Rating Scale for Depression (HAMD) total score.

    Time frame: From randomization to response and remission (24 week))

    Response was defined as ≥50% decrease in the baseline HAMD total score; remission was defined as the HAMD total score ≤7

Secondary outcomes

  1. The changes of Hamilton Rating Scale for Depression (HAMD) total score

    Time frame: From randomization to endpoint (Week 24)

    To measure the change of the severity of depressive symptoms

  2. The incidence and nature of overall adverse events

    Time frame: From enrollment to endpoint (Week 24)

  3. The incidence and nature of drug-related adverse events

    Time frame: From enrollment to endpoint (Week 24)

  4. The number of subject withdrawal due to adverse events during double-blind phase

    Time frame: From randomization to endpoint(Week 24)

  5. The changes of Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score

    Time frame: From randomization to endpoint (Week 24)

  6. The changes of Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER)

    Time frame: From randomization to endpoint (Week 24)

    The FIBSER is a self-report instrument assessing three domains of medication side effects within the past week

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Measurement-based Care vs. Standard Care for Major Depressive Disorder: a Randomized Controlled Trial With Masked Raters

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 16, 2014
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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