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

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ClinicalTrials.gov Identifier: NCT01764867
Recruitment Status : Unknown
Verified January 2013 by Yiru FANG, Shanghai Mental Health Center.
Recruitment status was:  Recruiting
First Posted : January 10, 2013
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
Yiru FANG, Shanghai Mental Health Center

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram Drug: Mirtazapine Other: modified electroconvulsive therapy Other: repetitive transcranial magnetic stimulation Drug: Fluoxetine Drug: Citalopram Drug: Paroxetine Drug: Sertraline Drug: Fluvoxamine Drug: Venlafaxine Drug: Duloxetine Drug: Bupropion Drug: Trazodone Phase 4

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  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Algorithm Guided Treatment Strategies for Major Depressive Disorder
Study Start Date : June 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: 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 Name: 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 Name: rTMS
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: 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: Escitalopram
Escitalopram 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: Mirtazapine
Mirtazapine 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Remission defined as endpoint the Quick Inventory of Depressive Symptomatology (16-item) (QIDS-SR16) total score ≤ 5 [ Time Frame: 12 weeks ]
  2. 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.

  3. 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.


Other Outcome Measures:
  1. Relapse rate [ Time Frame: 6 months ]
    Relapse rate will be measured at the end of 6 months after remission.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764867


Contacts
Contact: Zhiguo Wu, M.D. 862134289888 ext 3528 wu_zhiguo@yahoo.com.cn

Locations
China
Shanghai Mental Health Center Recruiting
Shanghai, China, 200030
Contact: Zhiguo Wu, M.D.    862134289888 ext 3528    wu_zhiguo@yahoo.com.cn   
Principal Investigator: Yiru Fang, Ph.D., M.D.         
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
Principal Investigator: Yiru Fang, Ph.D., M.D. Shanghai Mental Health Center

Responsible Party: Yiru FANG, Ph.D., Professor of Psychiatry, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT01764867     History of Changes
Other Study ID Numbers: 2012BAI01B04-MDD
2012BAI01B04 ( Other Grant/Funding Number: 2012BAI01B04 )
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by Yiru FANG, Shanghai Mental Health Center:
major depressive disorder
algorithm guided treatment
treatment as usual
escitalopram
mirtazapine
transcranial magnetic stimulation (rTMS)
modified electroconvulsive therapy (mECT)
remission
relapse
quality of life

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Sertraline
Fluoxetine
Paroxetine
Trazodone
Fluvoxamine
Bupropion
Venlafaxine Hydrochloride
Mianserin
Duloxetine Hydrochloride
Mirtazapine
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs