Major Depressive DisorderPhase 4AGTs-MDDNCT01764867
Algorithm Guided Treatment Strategies for Major Depressive Disorder
A Phase 4 study testing Escitalopram, Mirtazapine and modified electroconvulsive therapy in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this study is to compare treatment outcomes between measurement based Algorithm Guided Treatment and Treatment As Usual strategies in a Chinese population with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram, Mirtazapine and modified electroconvulsive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for single or recurrent nonpsychotic major depressive disorder
- Age 18-75
- Written informed consent completed
- Scores 14 or higher on the 17-item Hamilton Depression Rating Scale
- Initial treatment with escitalopram or mirtazapine or other antidepressants is clinically appropriate
Who cannot join
- History of bipolar disorder
- Concurring psychotic disorders
- Scores 3 or higher on item 3 (suicidal) of HRSD-17
- History of nonresponse to an adequate trial of escitalopram and/or mirtazapine
- Has general medical condition, which contraindicates any leve 1 or 2 treatment option
- Is on concomitant medication, which contraindicates any leve 1 or 2 treatment option
- Any contraindication for mECT or rTMS
- Is pregnant or breast feeding or is planning to get pregnant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, 200030
Zhiguo Wu, M.D., 862134289888 ext. 3528, wu_zhiguo@yahoo.com.cn
Yiru Fang, Ph.D., M.D.
About this study
The purpose of this study is to compare treatment outcomes between measurement based Algorithm Guided Treatment and Treatment As Usual strategies in a Chinese population with major depressive disorder.
Read the detailed description
The AGT arm includes a 2-step medication monotherapy and a combination treatment algorithm. The first step (level 1) includes two medication monotherapy options: escitalopram and mirtazapine. For those participants who don't remit with the initial intervention after up to 6 to 12-week treatment, the second step (level 2) with a variety of treatment options will be provided. In level 2 intervention, a switch strategy for those who don't remit with escitalopram will be switched to mirtazapine, or for those who don't remit with mirtazapine will be switched to escitalopram, combination strategy (i.e. escitalopram plus mirtazapine) and augmentation strategy (i.e. escitalopram or mirtazapine plus either rTMS or mECT). Participants who don't get remission in level 1 intervention will be encouraged to enter level 2 interventions based on intend-to-treatment principle. The TAU arm as control intervention is performed using the psychiatrist's individual discretion based on his/her expertise and knowledge.
Participants will be recruited consecutively in 8 psychiatric settings across China and randomized into any of the two initial interventions of AGT or TAU arm. Follow-up interviews will be performed monthly for all participants who finish any acute treatment of AGT or TAU. The follow-up period will last up to 6 months.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram, Mirtazapine, modified electroconvulsive therapy, repetitive transcranial magnetic stimulation, Fluoxetine
- Keywords
- major depressive disorder, algorithm guided treatment, treatment as usual, escitalopram, mirtazapine, transcranial magnetic stimulation (rTMS), modified electroconvulsive therapy (mECT), remission, relapse, quality of life
- Medical subject headings
- Depressive Disorder, Major, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
Recommended dosage range of escitalopram is 10-20mg per day. The duration will last up to 6-12 weeks until progression or unacceptable intolerability develops.
MirtazapineDrug
Also called Remeron
Recommended dosage range of mirtazapine is 30-45mg per day. The duration will last up to 6-12 weeks until progression or unacceptable intolerability develops.
modified electroconvulsive therapyOther
Also called mECT
Up to 6-10 sessions of mECT will be performed for selected participants who fails to remit to initial AGT intervention during 6 to 12-week period.
repetitive transcranial magnetic stimulationOther
Also called rTMS
Up to 20 sessions of rTMS will be performed for selected participants who fails to remit to initial AGT intervention during 6 to 12-week period.
FluoxetineDrug
Fluoxetine may be prescribed for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
CitalopramDrug
Citalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
EscitalopramDrug
Escitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
ParoxetineDrug
Paroxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
SertralineDrug
Sertraline may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
FluvoxamineDrug
Fluvoxamine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
VenlafaxineDrug
Venlafaxine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
DuloxetineDrug
Duloxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
MirtazapineDrug
Mirtazapine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
BupropionDrug
Bupropion may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
TrazodoneDrug
Trazodone may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
| Study group | Role | What they receive |
|---|---|---|
| Algorithm Guided Treatment (AGT) | Active comparator | Algorithm Guided Treatment (AGT) strategies include two steps. In the first step, participants will be randomly assigned to escitalopram (10-20mg/d) or mirtazapine (30-45mg/d) group. In the second step those non-remitted will be allocated into a set of different intervention groups including mirtazapine monotherapy (only for those taken escitalopram in the first step), escitalopram monotherapy (only for those taken mirtazapine in the first step), or combination therapies (i.e. escitalopram plus mirtazapine, escitalopram or mirtazapine plus either modified electroconvulsive therapy with 6-10 sessions or repetitive transcranial magnetic stimulation with 20 sessions respectively) according to intent-to-treat principle. Medication dosage in combination therapy has the same range as the first. Receives: Drug: Escitalopram; Drug: Mirtazapine; Other: modified electroconvulsive therapy; Other: repetitive transcranial magnetic stimulation |
| Treatment As Usual (TAU) | Active comparator | This control arm refers to routine antidepressant treatment strategies for participants. Any of the new-generation antidepressants including fluoxetine, citalopram, escitalopram, paroxetine, sertraline, fluvoxamine, venlafaxine, duloxetine, mirtazapine, bupropion, or trazodone, which are all available in Chinese psychiatric clinics, may be used for participants who are randomly assigned to this treatment arm based on clinician's expertise and clinical judgement. The dosage range of any of the above antidepressants depends on clinician's judgement. The follow-up period will last up to 6-12 weeks. During follow-ups, clinician can decide to continue current treatment or start a switch or combination strategy based on his/her own clinical judgement. Receives: Drug: Fluoxetine; Drug: Citalopram; Drug: Escitalopram; Drug: Paroxetine; Drug: Sertraline; Drug: Fluvoxamine; Drug: Venlafaxine; Drug: Duloxetine; Drug: Mirtazapine; Drug: Bupropion; Drug: Trazodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission defined as endpoint 17-item Hamilton Rating Scale for Depression (HRSD-17) total score ≤ 7
Acute treatment will last at least 6 weeks if remission occurs, or up to 12 weeks. Endpoint total score in HRSD-17 at up to 12 weeks will be measured to determine wether remission occurs.
Measured: 12 weeks
Secondary outcomes (3)
Remission defined as endpoint the Quick Inventory of Depressive Symptomatology (16-item) (QIDS-SR16) total score ≤ 5
Measured: 12 weeks
Frequency and intensity of adverse events
Self-report and clinician rating frequency and intensity of adverse events will be measured at up to 12 weeks.
Measured: 12 weeks
Quality of life
Change from baseline in 6-item Quality of life Inventory will be measured at up to 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiru FANG, Shanghai Mental Health Center
- Investigators
- Yiru Fang, Ph.D., M.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764867
- Sponsor's protocol ID
- 2012BAI01B04-MDD
- Other IDs
- 2012BAI01B04
- Acronym
- AGTs-MDD
- Status last verified
- Jan 2013
- First submitted
- 15 Dec 2012
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhu Y, Wang F, Wang F, Liu H, Guo X, Wang Z, He R, Wu X, Cao L, Wu Z, Peng D, Fang Y. Program of algorithm for pharmacological treatment of major depressive disorder in China: Benefits or not? Heliyon. 2023 Oct 17;9(11):e20951. doi: 10.1016/j.heliyon.2023.e20951. eCollection 2023 Nov.
PubMed 37920522
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algorithm Guided Treatment Strategies for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01764867
- Acronym / sponsor ID
- AGTs-MDD / 2012BAI01B04-MDD
- Conditions
- Major Depressive Disorder
- Keywords
- major depressive disorder, algorithm guided treatment, treatment as usual, escitalopram, mirtazapine, transcranial magnetic stimulation (rTMS), modified electroconvulsive therapy (mECT), remission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Jan 2013 (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.
The purpose of this study is to compare treatment outcomes between measurement based Algorithm Guided Treatment and Treatment As Usual strategies in a Chinese population with major depressive disorder.
Detailed description
The AGT arm includes a 2-step medication monotherapy and a combination treatment algorithm. The first step (level 1) includes two medication monotherapy options: escitalopram and mirtazapine. For those participants who don't remit with the initial intervention after up to 6 to 12-week treatment, the second step (level 2) with a variety of treatment options will be provided. In level 2 intervention, a switch strategy for those who don't remit with escitalopram will be switched to mirtazapine, or for those who don't remit with mirtazapine will be switched to escitalopram, combination strategy (i.e. escitalopram plus mirtazapine) and augmentation strategy (i.e. escitalopram or mirtazapine plus either rTMS or mECT). Participants who don't get remission in level 1 intervention will be encouraged to enter level 2 interventions based on intend-to-treatment principle. The TAU arm as control intervention is performed using the psychiatrist's individual discretion based on his/her expertise and knowledge.
Participants will be recruited consecutively in 8 psychiatric settings across China and randomized into any of the two initial interventions of AGT or TAU arm. Follow-up interviews will be performed monthly for all participants who finish any acute treatment of AGT or TAU. The follow-up period will last up to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algorithm Guided Treatment (AGT) | Active comparator | Drug: Escitalopram, Drug: Mirtazapine, Other: modified electroconvulsive therapy, Other: repetitive transcranial magnetic stimulationAlgorithm Guided Treatment (AGT) strategies include two steps. In the first step, participants will be randomly assigned to escitalopram (10-20mg/d) or mirtazapine (30-45mg/d) group. In the second step those non-remitted will be allocated into a set of different intervention groups including mirtazapine monotherapy (only for those taken escitalopram in the first step), escitalopram monotherapy (only for those taken mirtazapine in the first step), or combination therapies (i.e. escitalopram plus mirtazapine, escitalopram or mirtazapine plus either modified electroconvulsive therapy with 6-10 sessions or repetitive transcranial magnetic stimulation with 20 sessions respectively) according to intent-to-treat principle. Medication dosage in combination therapy has the same range as the first. |
| Treatment As Usual (TAU) | Active comparator | Drug: Fluoxetine, Drug: Citalopram, Drug: Escitalopram, Drug: Paroxetine, Drug: Sertraline, Drug: Fluvoxamine, Drug: Venlafaxine, Drug: Duloxetine, Drug: Mirtazapine, Drug: Bupropion, Drug: TrazodoneThis control arm refers to routine antidepressant treatment strategies for participants. Any of the new-generation antidepressants including fluoxetine, citalopram, escitalopram, paroxetine, sertraline, fluvoxamine, venlafaxine, duloxetine, mirtazapine, bupropion, or trazodone, which are all available in Chinese psychiatric clinics, may be used for participants who are randomly assigned to this treatment arm based on clinician's expertise and clinical judgement. The dosage range of any of the above antidepressants depends on clinician's judgement. The follow-up period will last up to 6-12 weeks. During follow-ups, clinician can decide to continue current treatment or start a switch or combination strategy based on his/her own clinical judgement. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for single or recurrent nonpsychotic major depressive disorder
- Age 18-75
- Written informed consent completed
- Scores 14 or higher on the 17-item Hamilton Depression Rating Scale
- Initial treatment with escitalopram or mirtazapine or other antidepressants is clinically appropriate
Key exclusion criteria (8 listed)
- History of bipolar disorder
- Concurring psychotic disorders
- Scores 3 or higher on item 3 (suicidal) of HRSD-17
- History of nonresponse to an adequate trial of escitalopram and/or mirtazapine
- Has general medical condition, which contraindicates any leve 1 or 2 treatment option
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 |
|---|---|---|
| EscitalopramAlso: LexaproRecommended dosage range of escitalopram is 10-20mg per day. The duration will last up to 6-12 weeks until progression or unacceptable intolerability develops. | Drug | Algorithm Guided Treatment (AGT) |
| MirtazapineAlso: RemeronRecommended dosage range of mirtazapine is 30-45mg per day. The duration will last up to 6-12 weeks until progression or unacceptable intolerability develops. | Drug | Algorithm Guided Treatment (AGT) |
| modified electroconvulsive therapyAlso: mECTUp to 6-10 sessions of mECT will be performed for selected participants who fails to remit to initial AGT intervention during 6 to 12-week period. | Other | Algorithm Guided Treatment (AGT) |
| repetitive transcranial magnetic stimulationAlso: rTMSUp to 20 sessions of rTMS will be performed for selected participants who fails to remit to initial AGT intervention during 6 to 12-week period. | Other | Algorithm Guided Treatment (AGT) |
| FluoxetineFluoxetine may be prescribed for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
| CitalopramCitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
| EscitalopramEscitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
| ParoxetineParoxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
| SertralineSertraline may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
| FluvoxamineFluvoxamine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
| VenlafaxineVenlafaxine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
| DuloxetineDuloxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
| MirtazapineMirtazapine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
| BupropionBupropion may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
| TrazodoneTrazodone may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. | Drug | Treatment As Usual (TAU) |
Primary outcome
Remission defined as endpoint 17-item Hamilton Rating Scale for Depression (HRSD-17) total score ≤ 7
Time frame: 12 weeks
Acute treatment will last at least 6 weeks if remission occurs, or up to 12 weeks. Endpoint total score in HRSD-17 at up to 12 weeks will be measured to determine wether remission occurs.
3 secondary outcomes
Remission defined as endpoint the Quick Inventory of Depressive Symptomatology (16-item) (QIDS-SR16) total score ≤ 5
Time frame: 12 weeks
Frequency and intensity of adverse events
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
- Derived from this study: PubMed 37920522Zhu Y, Wang F, Wang F, Liu H, Guo X, Wang Z, He R, Wu X, Cao L, Wu Z, Peng D, Fang Y. Program of algorithm for pharmacological treatment of major depressive disorder in China: Benefits or not? Heliyon. 2023 Oct 17;9(11):e20951. doi: 10.1016/j.heliyon.2023.e20951. eCollection 2023 Nov.
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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.
Yiru Fang, Ph.D., M.D. principal investigator
Shanghai Mental Health Center
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 Escitalopram, Mirtazapine and modified electroconvulsive therapy in people with Major Depressive Disorder, run by Shanghai Mental Health Center 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 8 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: status not confirmed, as of the sponsor's last update on 10 Jan 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiguo Wu, M.D. (862134289888 ext. 3528, wu_zhiguo@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission defined as endpoint 17-item Hamilton Rating Scale for Depression (HRSD-17) total score ≤ 7 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764867, which also lists 1 linked publication.
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 10 Jan 2013.