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

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ClinicalTrials.gov Identifier: NCT02191124
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Gang Wang, Capital Medical University

Brief 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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Paroxetine Drug: Mirtazapine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Measurement-based Care vs. Standard Care for Major Depressive Disorder: a Randomized Controlled Trial With Masked Raters
Study Start Date : June 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : May 2013


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 Name: 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 Name: 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 Name: 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 Name: Remeron




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191124


Locations
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China, Beijing
Beijing Anding Hospital
Beijing, Beijing, China, 100088
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Gang Wang, MD;PhD Beijing Anding Hospital, Capital Medical University

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Responsible Party: Gang Wang, vice-director of Affective Disorder Center, Beijing Anding Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT02191124     History of Changes
Other Study ID Numbers: 2009-1051
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Gang Wang, Capital Medical University:
Measurement-based care
Unipolar depression
Outpatients
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Mirtazapine
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic alpha-2 Receptor Antagonists