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| ID | Type | Description | Link |
|---|---|---|---|
| 2012BAI01B04 | Other Grant/Funding Number | 2012BAI01B04 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Remission defined as endpoint the Quick Inventory of Depressive Symptomatology (16-item) (QIDS-SR16) total score ≤ 5 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate | Relapse rate will be measured at the end of 6 months after remission. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiguo Wu, M.D. | Contact | 862134289888 | 3528 | wu_zhiguo@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yiru Fang, Ph.D., M.D. | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37920522 | Derived | 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. |
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| Mirtazapine | Drug | 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. |
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| modified electroconvulsive therapy | Other | 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. |
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| repetitive transcranial magnetic stimulation | Other | 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. |
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| Fluoxetine | Drug | Fluoxetine may be prescribed for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
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| Citalopram | Drug | Citalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
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| Escitalopram | Drug | Escitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
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| Paroxetine | Drug | Paroxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
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| Sertraline | Drug | Sertraline may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
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| Fluvoxamine | Drug | Fluvoxamine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
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| Venlafaxine | Drug | Venlafaxine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
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| Duloxetine | Drug | Duloxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
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| Mirtazapine | Drug | Mirtazapine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
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| Bupropion | Drug | Bupropion may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
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| Trazodone | Drug | Trazodone may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement. |
|
| 12 weeks |
| Quality of life | Change from baseline in 6-item Quality of life Inventory will be measured at up to 12 weeks. | 12 weeks |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D000078785 | Mirtazapine |
| D050781 | Transcranial Magnetic Stimulation |
| D005473 | Fluoxetine |
| D015283 | Citalopram |
| D017374 | Paroxetine |
| D020280 | Sertraline |
| D016666 | Fluvoxamine |
| D000069470 | Venlafaxine Hydrochloride |
| D000068736 | Duloxetine Hydrochloride |
| D016642 | Bupropion |
| D014196 | Trazodone |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D015057 | 1-Naphthylamine |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010091 | Oximes |
| D006898 | Hydroxylamines |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D008055 | Lipids |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D010879 | Piperazines |
| D011728 | Pyridones |
| D011725 | Pyridines |
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