Algorithm Guided Treatment Strategies for Major Depressive Disorder - Full Text View

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:

MedlinePlus related topics: Depression Mental Health

Drug Information available for: Trazodone Trazodone hydrochloride Bupropion hydrochloride Bupropion Fluvoxamine Fluoxetine Fluoxetine hydrochloride Citalopram hydrobromide Citalopram Fluvoxamine maleate Paroxetine Paroxetine hydrochloride Sertraline hydrochloride Sertraline Mirtazapine Venlafaxine Venlafaxine hydrochloride Paroxetine hydrochloride hemihydrate Duloxetine Duloxetine hydrochloride Paroxetine Mesylate Escitalopram oxalate

U.S. FDA Resources

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.

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

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:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Trazodone
Fluvoxamine
Citalopram
Fluoxetine
Paroxetine
Sertraline
Venlafaxine
Duloxetine
Mianserin

Bupropion
Mirtazapine
Dexetimide
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013

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