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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,080
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.
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.
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.
Shanghai Mental Health Center
Shanghai, China
RECRUITINGRemission 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.
Time frame: 12 weeks
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
Self-report and clinician rating frequency and intensity of adverse events will be measured at up to 12 weeks.
Time frame: 12 weeks
Quality of life
Change from baseline in 6-item Quality of life Inventory will be measured at up to 12 weeks.
Time frame: 12 weeks
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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.
Fluoxetine may be prescribed for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Citalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Escitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Paroxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Sertraline may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Fluvoxamine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Venlafaxine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Duloxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Mirtazapine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Bupropion may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Trazodone may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.