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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Shanghai Mental Health Center
Sponsor:
Information provided by (Responsible Party):
Yiru FANG, Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT01764867
First received: December 15, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Algorithm Guided Treatment Strategies for Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Shanghai Mental Health Center:

Primary Outcome Measures:
  • Remission defined as endpoint 17-item Hamilton Rating Scale for Depression (HRSD-17) total score ≤ 7 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Remission defined as endpoint the Quick Inventory of Depressive Symptomatology (16-item) (QIDS-SR16) total score ≤ 5 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Frequency and intensity of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Self-report and clinician rating frequency and intensity of adverse events will be measured at up to 12 weeks.

  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in 6-item Quality of life Inventory will be measured at up to 12 weeks.


Other Outcome Measures:
  • Relapse rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Relapse rate will be measured at the end of 6 months after remission.


Estimated Enrollment: 1080
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 15, 2012
Last Updated: January 8, 2013
Health Authority: China: Ethics Committee

Keywords provided by 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
Dexetimide
Citalopram
Bupropion
Duloxetine
Sertraline
Paroxetine
Fluoxetine
Venlafaxine
Mirtazapine
Mianserin
Fluvoxamine
Trazodone
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists

ClinicalTrials.gov processed this record on September 18, 2014