Algorithm Guided Treatment Strategies for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— AGTs-MDD  

Official title:

Algorithm Guided Treatment Strategies for Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01764867
• Other study ID #: 2012BAI01B04-MDD
• Secondary ID: 2012BAI01B04
• Status: Recruiting
• Phase: Phase 4
• First received: December 15, 2012
• Last updated: January 8, 2013
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2013
• Source: Shanghai Mental Health Center
• Contact: Zhiguo Wu, M.D.
• Phone: 862134289888
• Email: wu_zhiguo[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1080
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram
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.
• Mirtazapine
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.

Other:
• modified electroconvulsive therapy
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.
• repetitive 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.

Drug:
• Fluoxetine
Fluoxetine may be prescribed for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
• Citalopram
Citalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
• Escitalopram
Escitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
• Paroxetine
Paroxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
• Sertraline
Sertraline may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
• Fluvoxamine
Fluvoxamine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
• Venlafaxine
Venlafaxine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
• Duloxetine
Duloxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
• Mirtazapine
Mirtazapine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
• Bupropion
Bupropion may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
• Trazodone
Trazodone may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relapse rate	Relapse rate will be measured at the end of 6 months after remission.	6 months	No
Primary	Remission 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.	12 weeks	No
Secondary	Remission defined as endpoint the Quick Inventory of Depressive Symptomatology (16-item) (QIDS-SR16) total score = 5		12 weeks	No
Secondary	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.	12 weeks	Yes
Secondary	Quality of life	Change from baseline in 6-item Quality of life Inventory will be measured at up to 12 weeks.	12 weeks	No