Clinical trial NCT01764867: Algorithm Guided Treatment Strategies for Major Depressive Disorder
Official title: Algorithm Guided Treatment Strategies for Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
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
relapse
quality of life
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Remission defined as endpoint 17-item Hamilton Rating Scale for Depression (HRSD-17) total score ≤ 7
timeFrame: 12 weeks
Secondary outcomes:
measure: Remission defined as endpoint the Quick Inventory of Depressive Symptomatology (16-item) (QIDS-SR16) total score ≤ 5
timeFrame: 12 weeks
measure: Frequency and intensity of adverse events
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
Other outcomes:
measure: Relapse rate
timeFrame: 6 months
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Yiru Fang, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: