Major Depressive Disorder
Conditions
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
Brief 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.
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.
Interventions
DRUGEscitalopram
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.
DRUGMirtazapine
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.
OTHERrepetitive transcranial magnetic stimulation
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.
DRUGFluoxetine
Fluoxetine may be prescribed for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
DRUGCitalopram
Citalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
DRUGParoxetine
Paroxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
DRUGSertraline
Sertraline may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
DRUGFluvoxamine
Fluvoxamine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
DRUGVenlafaxine
Venlafaxine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
DRUGDuloxetine
Duloxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
DRUGBupropion
Bupropion may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
DRUGTrazodone
Trazodone may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission defined as endpoint 17-item Hamilton Rating Scale for Depression (HRSD-17) total score ≤ 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 weeks | Self-report and clinician rating frequency and intensity of adverse events will be measured at up to 12 weeks. |
| Quality of life | 12 weeks | Change from baseline in 6-item Quality of life Inventory will be measured at up to 12 weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Relapse rate | 6 months | Relapse rate will be measured at the end of 6 months after remission. |
Countries
China
Contacts
Primary ContactZhiguo Wu, M.D.
Outcome results
None listed