Algorithm Guided Treatment Strategies for Major Depressive Disorder

NCT01764867 | Unknown Phase 4

• 2 other identifiers: 2012BAI01B04-MDD2012BAI01B04
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

major depressive disorder; algorithm guided treatment; treatment as usual; escitalopram; mirtazapine; transcranial magnetic stimulation (rTMS); modified electroconvulsive therapy (mECT); remission; relapse; quality of life

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

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

  12 weeks

• Frequency and intensity of adverse events

  12 weeks

• Quality of life

  12 weeks

Other Outcomes (1)

• Relapse rate

  6 months

Study Arms (2)

Algorithm Guided Treatment (AGT)

ACTIVE COMPARATOR

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; Drug: Mirtazapine; Other: modified electroconvulsive therapy; Other: repetitive transcranial magnetic stimulation

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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; Drug: Citalopram; Drug: Escitalopram; Drug: Paroxetine; Drug: Sertraline; Drug: Fluvoxamine; Drug: Venlafaxine; Drug: Duloxetine; Drug: Mirtazapine; Drug: Bupropion; Drug: Trazodone

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro

Algorithm Guided Treatment (AGT)

Mirtazapine DRUG

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.

Also known as: Remeron

Algorithm Guided Treatment (AGT)

modified electroconvulsive therapy OTHER

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.

Also known as: mECT

Algorithm Guided Treatment (AGT)

repetitive transcranial magnetic stimulation OTHER

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.

Also known as: rTMS

Algorithm Guided Treatment (AGT)

Fluoxetine DRUG

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

Treatment As Usual (TAU)

Citalopram DRUG

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

Treatment As Usual (TAU)

Paroxetine DRUG

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

Treatment As Usual (TAU)

Sertraline DRUG

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

Treatment As Usual (TAU)

Fluvoxamine DRUG

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

Treatment As Usual (TAU)

Venlafaxine DRUG

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

Treatment As Usual (TAU)

Duloxetine DRUG

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

Treatment As Usual (TAU)

Bupropion DRUG

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

Treatment As Usual (TAU)

Trazodone DRUG

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

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

RECRUITING

Related Publications (1)

• Zhu Y, Wang F, Wang F, Liu H, Guo X, Wang Z, He R, Wu X, Cao L, Wu Z, Peng D, Fang Y. Program of algorithm for pharmacological treatment of major depressive disorder in China: Benefits or not? Heliyon. 2023 Oct 17;9(11):e20951. doi: 10.1016/j.heliyon.2023.e20951. eCollection 2023 Nov.

  PMID: 37920522 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Interventions

Escitalopram; Mirtazapine; Transcranial Magnetic Stimulation; Fluoxetine; Citalopram; Paroxetine; Sertraline; Fluvoxamine; Venlafaxine Hydrochloride; Duloxetine Hydrochloride; Bupropion; Trazodone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Magnetic Field Therapy; Therapeutics; Piperidines; Heterocyclic Compounds, 1-Ring; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Oximes; Hydroxylamines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids; Thiophenes; Sulfur Compounds; Propiophenones; Ketones; Piperazines; Pyridones; Pyridines

Study Officials

• Yiru Fang, Ph.D., M.D.

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiguo Wu, M.D.

CONTACT

862134289888; wu_zhiguo@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Professor of Psychiatry

Study Record Dates

• First Submitted: December 15, 2012
• First Posted: January 10, 2013
• Study Start: June 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

CN (1)