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Major Depressive Disorder | Algorithm Guided Treatment Strategies for Major Depressive Disorder

Major Depressive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:EscitalopramRecommended dosage range of escitalopram is 10-20mg per day. The duration will last up to 6-12 weeks until progression or unacceptable intolerability develops.

Drug:MirtazapineRecommended 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 therapyUp 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:repetitive transcranial magnetic stimulationUp 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:FluoxetineFluoxetine may be prescribed for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Drug:CitalopramCitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Drug:EscitalopramEscitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Drug:ParoxetineParoxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Drug:SertralineSertraline may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Drug:FluvoxamineFluvoxamine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Drug:VenlafaxineVenlafaxine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Drug:DuloxetineDuloxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Drug:MirtazapineMirtazapine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Drug:BupropionBupropion may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Drug:TrazodoneTrazodone may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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.

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.

Study Status

Unknown status

Start Date: June 2012

Completed Date: December 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Remission defined as endpoint 17-item Hamilton Rating Scale for Depression (HRSD-17) total score ≤ 7

Secondary Outcome: Remission defined as endpoint the Quick Inventory of Depressive Symptomatology (16-item) (QIDS-SR16) total score ≤ 5

Study sponsors, principal investigator, and references

Principal Investigator: Yiru Fang, Ph.D., M.D.

Lead Sponsor: Shanghai Mental Health Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01764867

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