Algorithm Guided Treatment Strategies for Major Depressive Disorder

Condition(s) targeted: Major Depressive Disorder

Intervention: Escitalopram (Drug); Mirtazapine (Drug); modified electroconvulsive therapy (Other); repetitive transcranial magnetic stimulation (Other); Fluoxetine (Drug); Citalopram (Drug); Escitalopram (Drug); Paroxetine (Drug); Sertraline (Drug); Fluvoxamine (Drug); Venlafaxine (Drug); Duloxetine (Drug); Mirtazapine (Drug); Bupropion (Drug); Trazodone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Shanghai Mental Health Center

Official(s) and/or principal investigator(s):
Yiru Fang, Ph.D., M.D., Principal Investigator, Affiliation: Shanghai Mental Health Center

Overall contact:
Zhiguo Wu, M.D., Phone: 862134289888, Ext: 3528, Email: wu_zhiguo@yahoo.com.cn

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.

Official title: Algorithm Guided Treatment Strategies for Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Remission defined as endpoint 17-item Hamilton Rating Scale for Depression (HRSD-17) total score ≤ 7

Secondary outcome:

Remission defined as endpoint the Quick Inventory of Depressive Symptomatology (16-item) (QIDS-SR16) total score ≤ 5

Frequency and intensity of adverse events

Quality of life

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Zhiguo Wu, M.D., Phone: 862134289888, Ext: 3528, Email: wu_zhiguo@yahoo.com.cn

Shanghai Mental Health Center, Shanghai 200030, China; Recruiting
Zhiguo Wu, M.D., Phone: 862134289888, Ext: 3528, Email: wu_zhiguo@yahoo.com.cn
Yiru Fang, Ph.D., M.D., Principal Investigator

Starting date: June 2012
Last updated: January 8, 2013