BMDD-2022: A Randomized Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depression

Sponsor

Chonnam National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06054321

Collaborator

(none)

400

Enrollment

Location

Arms

100.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: stepwise pharamacotherapy Drug: antidepressant monotherapy group	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

partial masking(participants, care providers, outcome assessor are not aware of treatment response scores in spite of opened status for prescribed information (mono vs step)

Primary Purpose:

Treatment

Official Title:

A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients

Actual Study Start Date :

Aug 3, 2022

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Good responder group-stepwise pharamacotherapy group Using multimodal serum biomaker scores, patients will be divided into good/poor responder. Then good responder group will be randomized into stepwise pharamacotherapy group vs antidepressant monotherapy(escitalopram) group. In the stepwise pharamacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.	Drug: stepwise pharamacotherapy In the stepwise pharamacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks. Other Names: escitalopram escitalopram with aripiprazole augementation escitalopram with lithium augumentation escitalopram with mirtazapine combination
Active Comparator: Good responder group-antidepressant monotherapy group Using multimodal serum biomaker scores, patients will be divided into good/poor responder. Then good responder group will be randomized into stepwise pharamacotherapy group vs antidepressant monotherapy(escitalopram) group. In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.	Drug: antidepressant monotherapy group In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks. Other Names: escitalopram monotherapy
Experimental: Poor responder group-stepwise pharamacotherapy group Using multimodal serum biomaker scores, patients will be divided into good/poor responder. Then poor responder group will be randomized into stepwise pharamacotherapy group vs antidepressant monotherapy(escitalopram) group. In the stepwise pharamacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.	Drug: stepwise pharamacotherapy In the stepwise pharamacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks. Other Names: escitalopram escitalopram with aripiprazole augementation escitalopram with lithium augumentation escitalopram with mirtazapine combination
Active Comparator: Poor responder group-antidepressant monotherapy group Using multimodal serum biomaker scores, patients will be divided into good/poor responder. Then poor responder group will be randomized into stepwise pharamacotherapy group vs antidepressant monotherapy(escitalopram) group. In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.	Drug: antidepressant monotherapy group In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks. Other Names: escitalopram monotherapy

Outcome Measures

Primary Outcome Measures

Remission and treatment response status by Hamilton Depression Rating Scale (HRDS) ≤7 [From baseline to 12 week, 1 year]
Remission defined by Hamilton Depression Rating Scale (HRDS) ≤7 and treatment response defined as ≥50% decrease in the baseline HAMD total score after stepwise psychopharmacotherapy or antidepressant monotherapy

Secondary Outcome Measures

The changes of Hamilton Rating Scale for Depression (HAMD) total score [From baseline to 12 week, 1 year]
To measure the change of the severity of depressive symptoms using observer rating scale after stepwise psychopharmacotherapy or antidepressant monotherapy
The changes of Hospital Anxiety and Depression Scale (HADS) total score, depression subscore, anxiety subscore [From baseline to 12 week, 1 year]
To measure the change of the severity of depressive symptoms using self-reported scale after stepwise psychopharmacotherapy or antidepressant monotherapy
The changes of Clinical Global Impression (CGI)-severity and improvement score [From baseline to 12 week, 1 year]
To measure the change of the global severity and improvement of depressive symptoms after stepwise psychopharmacotherapy or antidepressant monotherapy
The changes of Brief Psychiatric Rating Scale(BPRS) suicide item score [From baseline to 12 week, 1 year]
To measure the change of the suicidal-related severity after stepwise psychopharmacotherapy or antidepressant monotherapy
The changes of Sheehan Disability Scale score [From baseline to 12 week, 1 year]
To measure the change of the functional disability after stepwise psychopharmacotherapy or antidepressant monotherapy
The changes of EuroQol-5D score [From baseline to 12 week, 1 year]
To measure the change of quality of life status after stepwise psychopharmacotherapy or antidepressant monotherapy
The changes of Social and Occupational Functioning Assessment Scale score [From baseline to 12 week]
To measure the change of the social and occupational function after stepwise psychopharmacotherapy or antidepressant monotherapy
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period [First dose of study drug to last dose of study drug in the 26-week Treatment Period and 1 year after baseline]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

19 to 65 years
Diagnostic and Statistical Manual of Mental Disorders-5 criteria for MDD by study psychiatrists
Score≥17 on HDRS-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 DSM-IV diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder NOS, or other psychotic disorders
current major depressive disorder with psychotic features
History of organic psychosis, epilepsy, or seizure disorder
Current anorexia nervosa or obessive 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