Algorithm Guided Treatment Strategies for Major Depressive Disorder (AGTs-MDD)

Shanghai Mental Health Center

Status and phase

Unknown

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Venlafaxine

Drug: Trazodone

Drug: Fluoxetine

Drug: Mirtazapine

Drug: Citalopram

Other: modified electroconvulsive therapy

Drug: Escitalopram

Drug: Paroxetine

Drug: Bupropion

Other: repetitive transcranial magnetic stimulation

Drug: Sertraline

Drug: Duloxetine

Drug: Fluvoxamine

Study type

Interventional

Funder types

Other

Identifiers

NCT01764867

2012BAI01B04-MDD

2012BAI01B04 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,080 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,080 participants in 2 patient groups

Algorithm Guided Treatment (AGT)

Active Comparator group

Description:

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.

Treatment:

Drug: Escitalopram

Drug: Mirtazapine

Other: repetitive transcranial magnetic stimulation

Other: modified electroconvulsive therapy

Drug: Escitalopram

Treatment As Usual (TAU)

Active Comparator group

Description:

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.

Treatment:

Drug: Sertraline

Drug: Escitalopram

Drug: Venlafaxine

Drug: Duloxetine

Drug: Mirtazapine

Drug: Bupropion

Drug: Fluvoxamine

Drug: Trazodone

Drug: Escitalopram

Drug: Fluoxetine

Drug: Paroxetine