Clinical trial NCT02191124: The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial
Official title: Measurement-based Care vs. Standard Care for Major Depressive Disorder: a Randomized Controlled Trial With Masked Raters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Measurement-based care
Unipolar depression
Outpatients
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: The estimated time from randomization to response and remission according to Hamilton Rating Scale for Depression (HAMD) total score.
timeFrame: From randomization to response and remission (24 week))
Secondary outcomes:
measure: The changes of Hamilton Rating Scale for Depression (HAMD) total score
timeFrame: From randomization to endpoint (Week 24)
measure: The incidence and nature of overall adverse events
timeFrame: From enrollment to endpoint (Week 24)
measure: The incidence and nature of drug-related adverse events
timeFrame: From enrollment to endpoint (Week 24)
measure: The number of subject withdrawal due to adverse events during double-blind phase
timeFrame: From randomization to endpoint(Week 24)
measure: The changes of Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score
timeFrame: From randomization to endpoint (Week 24)
measure: The changes of Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER)
timeFrame: From randomization to endpoint (Week 24)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital
state: Beijing
Study officials:
affiliation: Beijing Anding Hospital, Capital Medical University
name: Gang Wang, MD;PhD
role: PRINCIPAL_INVESTIGATOR
References: