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

January 8, 2013 updated by: Yiru FANG, Shanghai Mental Health Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1080

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
        • Principal Investigator:
          • Yiru Fang, Ph.D., M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Algorithm Guided Treatment (AGT)
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.
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.
Other Names:
  • Lexapro
Drug: 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 Names:
  • Remeron
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.
Other Names:
  • mECT
Other: 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.
Other Names:
  • rTMS
Drug: Escitalopram
Escitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Mirtazapine
Mirtazapine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Active Comparator: Treatment As Usual (TAU)
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.
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.
Other Names:
  • Lexapro
Drug: 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 Names:
  • Remeron
Drug: Escitalopram
Escitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Mirtazapine
Mirtazapine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Fluoxetine
Fluoxetine may be prescribed for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Citalopram
Citalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Paroxetine
Paroxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Sertraline
Sertraline may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Fluvoxamine
Fluvoxamine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Venlafaxine
Venlafaxine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Duloxetine
Duloxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Bupropion
Bupropion may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
Drug: Trazodone
Trazodone may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission defined as endpoint 17-item Hamilton Rating Scale for Depression (HRSD-17) total score ≤ 7
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission defined as endpoint the Quick Inventory of Depressive Symptomatology (16-item) (QIDS-SR16) total score ≤ 5
Time Frame: 12 weeks
12 weeks
Frequency and intensity of adverse events
Time Frame: 12 weeks
Self-report and clinician rating frequency and intensity of adverse events will be measured at up to 12 weeks.
12 weeks
Quality of life
Time Frame: 12 weeks
Change from baseline in 6-item Quality of life Inventory will be measured at up to 12 weeks.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse rate
Time Frame: 6 months
Relapse rate will be measured at the end of 6 months after remission.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Investigators

  • Principal Investigator: Yiru Fang, Ph.D., M.D., Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 15, 2012

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012BAI01B04-MDD
  • 2012BAI01B04 (Other Grant/Funding Number: 2012BAI01B04)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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