Major Depressive DisorderPhase 4NCT02191124
The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial
A Phase 4 study testing Paroxetine and Mirtazapine in people with Major Depressive Disorder, run by Capital Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Paroxetine and Mirtazapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to May 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Paroxetine, Mirtazapine
- Keywords
- Measurement-based care, Unipolar depression, Outpatients
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParoxetineDrug
Also called Seroxat
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.
MirtazapineDrug
Also called Remeron
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
| Study group | Role | What they receive |
|---|---|---|
| measurement-based care | Experimental | 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. Receives: Drug: Paroxetine; Drug: Mirtazapine |
| Standard treatment | Active comparator | 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. Receives: Drug: Paroxetine; Drug: Mirtazapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From randomization to response and remission (24 week))
Secondary outcomes (6)
The changes of Hamilton Rating Scale for Depression (HAMD) total score
To measure the change of the severity of depressive symptoms
Measured: From randomization to endpoint (Week 24)
The incidence and nature of overall adverse events
Measured: From enrollment to endpoint (Week 24)
The incidence and nature of drug-related adverse events
Measured: From enrollment to endpoint (Week 24)
The number of subject withdrawal due to adverse events during double-blind phase
Measured: From randomization to endpoint(Week 24)
The changes of Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score
Measured: 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
Measured: From randomization to endpoint (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2011
- Primary completionNov 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wang, Capital Medical University
- Investigators
- Gang Wang, MD;PhD, Principal investigator, Beijing Anding Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191124
- Sponsor's protocol ID
- 2009-1051
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement-based Care vs. Standard Care for Major Depressive Disorder: a Randomized Controlled Trial With Masked Raters
- ClinicalTrials.gov ID
- NCT02191124
- Acronym / sponsor ID
- 2009-1051
- Conditions
- Major Depressive Disorder
- Keywords
- Measurement-based care, Unipolar depression, Outpatients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| measurement-based care | Experimental | Drug: Paroxetine, Drug: MirtazapineMBC 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. |
| Standard treatment | Active comparator | Drug: Paroxetine, Drug: MirtazapinePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParoxetineAlso: SeroxatPatients 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. | Drug | Standard treatment, measurement-based care |
| MirtazapineAlso: RemeronPatients 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 | Drug | Standard treatment, measurement-based care |
Primary outcome
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
6 secondary outcomes
The changes of Hamilton Rating Scale for Depression (HAMD) total score
Time frame: From randomization to endpoint (Week 24)
The incidence and nature of overall adverse events
Time frame: From enrollment to endpoint (Week 24)
The incidence and nature of drug-related adverse events
Time frame: From enrollment to endpoint (Week 24)
The number of subject withdrawal due to adverse events during double-blind phase
Time frame: From randomization to endpoint(Week 24)
The changes of Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score
Time frame: From randomization to endpoint (Week 24)
The changes of Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER)
Time frame: From randomization to endpoint (Week 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Wang, MD;PhD principal investigator
Beijing Anding Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paroxetine and Mirtazapine in people with Major Depressive Disorder, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014; AzTrials last refreshed its copy on 6 Nov 2026.