Psychopharmacotherapy for Depressive Patients (BMDD-2022)

Chonnam National University

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Drug: antidepressant monotherapy group; Drug: stepwise pharmacotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06054321

BMDD-2022

Details and patient eligibility

About

The primary purpose of this study is to compare the short (12 week) and long-term (1-year) efficacy and the tolerability between stepwise psychopharmacotherapy and antidepressant monotherapy for 12 weeks in adult patients with major depressive disorders, stratified by the multimodal serum biomarker scores.

Full description

This is prospective randomized controlled trials (RCT) to evaluate clinical impact of antidepressant monotherapy vs stepwise psychopharmacotherapy in patients with major depressive disorders, stratified by multimodal serum biomarker scores. Participants will be predicted treatment response based on the multimodal serum biomarker scores at baseline, will be categorized into good and poor treatment responders and then randomly assigned to two groups: stepwise pharmacotherapy group and antidepressant monotherapy group. The hypothesis is that in the good treatment responder, the depression remission will be achieved irrespective of treatment modality (stepwise pharmacotherapy or antidepressant monotherapy) group while in poor treatment responders, the treatment response of stepwise pharmacotherapy will be superior to those of antidepressant monotherapy.

Enrollment: 400 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 19 to 65 years
• Diagnostic and Statistical Manual of Mental Disorders-IV criteria for major depressive disorder by study psychiatrists
• Score≥17 on Hamilton Depression Rating Scale-17
• With ability to understand the objective of the study and sign informed consent
• Initiation of an antidepressant treatment for the current episode or no psychotropics excluding sleep pills or benzodiazepines within 1 month of participation

Exclusion criteria

• Current or lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or other psychotic disorders
• current major depressive disorder with psychotic features
• History of organic psychosis, epilepsy, or seizure disorder
• Current anorexia nervosa or obsessive compulsive disorder
• Unstable or uncontrolled medical condition
• Unable to complete the psychiatric assessment or comply with the medication regimen due to a severe physical illness
• History of anticonvulsant treatment
• Electroconvulsive therapy for the current depressive episode
• Hospitalization for any psychiatric diagnosis except depressive disorder (e.g., alcohol/drug dependence)
• severly high risk of suicide, self-harm or homicide by investigator's assessment
• Pregnant or breastfeeding
• lack of treatment information on the current depressive episode

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 4 patient groups

Good responder group-stepwise pharmacotherapy group

Experimental group

Description:

Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then good responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group. In the stepwise pharmacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.

Treatment:

Drug: stepwise pharmacotherapy

Good responder group-antidepressant monotherapy group

Active Comparator group

Description:

Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then good responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group. In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.

Treatment:

Drug: antidepressant monotherapy group

Poor responder group-stepwise pharmacotherapy group

Experimental group

Description:

Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then poor responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group. In the stepwise pharmacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.

Treatment:

Drug: stepwise pharmacotherapy

Poor responder group-antidepressant monotherapy group

Active Comparator group

Description:

Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then poor responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group. In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.

Treatment:

Drug: antidepressant monotherapy group