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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191124
• Other study ID #: 2009-1051
• Status: Completed
• Phase: Phase 4
• First received: July 10, 2014
• Last updated: July 15, 2014
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Beijing Anding Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))	No
Secondary	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)	No
Secondary	The incidence and nature of overall adverse events		From enrollment to endpoint (Week 24)	Yes
Secondary	The incidence and nature of drug-related adverse events		From enrollment to endpoint (Week 24)	Yes
Secondary	The number of subject withdrawal due to adverse events during double-blind phase		From randomization to endpoint(Week 24)	No
Secondary	The changes of Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score		From randomization to endpoint (Week 24)	No
Secondary	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)	Yes