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

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Paroxetine; Drug: Mirtazapine

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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100088
      • Beijing Anding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: measurement-based care; MBC allows psychiatrists to individualize treatment decisions for each patient based on the change of psychopathology and tolerance toward antidepressants. Treatment decisions were made by treating psychiatrists according to ratings of self-report scales obtained at each treatment visit. Paroxetine was started at 20mg/day and then raised to 30mg/day by week 4, 40mg/day by week 6, 50mg/day by week 8 and 60mg/day by week 10. Mirtazapine was started at 15mg/day and raised to 30mg/day by week 1 and 45mg/day by week 4. Dose adjustments were dependent on how long a patient had received a particular dose, symptom changes and side effects.	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.; Other Names: Seroxat; 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; Other Names: Remeron
Active Comparator: Standard treatment; Patients in the ST group are treated by their psychiatrists according to their clinical needs as judged at each outpatient visit, receiving either open-label paroxetine (20-60mg/day) or mirtazapine (15-45mg/day) within the therapeutic dose range.	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.; Other Names: Seroxat; 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; Other Names: Remeron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The estimated time from randomization to response and remission according to Hamilton Rating Scale for Depression (HAMD) total score.	Response was defined as ≥50% decrease in the baseline HAMD total score; remission was defined as the HAMD total score ≤7	From randomization to response and remission (24 week))

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of Hamilton Rating Scale for Depression (HAMD) total score	To measure the change of the severity of depressive symptoms	From randomization to endpoint (Week 24)
The incidence and nature of overall adverse events		From enrollment to endpoint (Week 24)
The incidence and nature of drug-related adverse events		From enrollment to endpoint (Week 24)
The number of subject withdrawal due to adverse events during double-blind phase		From randomization to endpoint(Week 24)
The changes of Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score		From randomization to endpoint (Week 24)
The changes of Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER)	The FIBSER is a self-report instrument assessing three domains of medication side effects within the past week	From randomization to endpoint (Week 24)

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Gang Wang, MD;PhD, Beijing Anding Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 15, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Outpatients; Unipolar depression; Measurement-based care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Serotonin 5-HT3 Receptor Antagonists; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Paroxetine; Mirtazapine
• Other Study ID Numbers: 2009-1051