Psychopharmacotherapy for Depressive Patients (BMDD-2022)

April 16, 2024 updated by: Jae-Min Kim, Chonnam National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Gwangju, Korea, Republic of, 61469
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
        • Principal Investigator:
          • Jae-Min Kim, Md, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Good responder group-stepwise pharmacotherapy group

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.
Drug: stepwise pharmacotherapy
In the stepwise pharmacotherapy 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 mirtazapine combination
  • escitalopram with aripiprazole augmentation
  • escitalopram with lithium augmentation
Active Comparator: Good responder group-antidepressant monotherapy group

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.
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 pharmacotherapy group

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.
Drug: stepwise pharmacotherapy
In the stepwise pharmacotherapy 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 mirtazapine combination
  • escitalopram with aripiprazole augmentation
  • escitalopram with lithium augmentation
Active Comparator: Poor responder group-antidepressant monotherapy group

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.
Drug: antidepressant monotherapy group
In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.
Other Names:
  • escitalopram monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission and treatment response status by Hamilton Depression Rating Scale
Time Frame: From baseline to 12 week, 1 year
Remission defined by total scores of Hamilton Depression Rating Scale (0-52; higher score indicates severe symptom) ≤7 and treatment response defined as ≥50% decrease in the baseline total scores of Hamilton Depression Rating Scale after stepwise psychopharmacotherapy or antidepressant monotherapy
From baseline to 12 week, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
Time Frame: 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
First dose of study drug to last dose of study drug in the 26-week Treatment Period and 1 year after baseline
The changes of Hamilton Rating Scale for Depression total score
Time Frame: 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
From baseline to 12 week, 1 year
The changes of Hospital Anxiety and Depression Scale total score, depression subscore, anxiety subscore
Time Frame: From baseline to 12 week, 1 year
The Hospital Anxiety and Depression Scale will be used to measure the change of the severity of depressive symptoms using observer rating scale after stepwise psychopharmacotherapy or antidepressant monotherapy. This scale consists of 14 items with a total score ranging from 0 to 42 and divided into two subscales: 7 items of the anxiety subscale (HADS-A) and 7 items of the depression subscale (HADS-D). Higher scores indicate more severe symptoms.
From baseline to 12 week, 1 year
The changes of Clinical Global Impression-severity and improvement score
Time Frame: From baseline to 12 week, 1 year
The Clinical Global Impression-severity and improvement score is used to measure the change of the global severity and improvement of depressive symptoms after stepwise psychopharmacotherapy or antidepressant monotherapy. This scale is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Higher scores indicate more severe psychopathology.
From baseline to 12 week, 1 year
The changes of Brief Psychiatric Rating Scale suicide item score
Time Frame: From baseline to 12 week, 1 year
Suicidality was evaluated with the suicide-related items on the Brief Psychiatric Rating Scale which assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. Among the 18 items, suicide item that ranges from 1 (not present) to 7 (extremely severe) will be used to measure the change sof suicidality after stepwise psychopharmacotherapy or antidepressant monotherapy.
From baseline to 12 week, 1 year
The changes of EuroQol-5 Dimension score
Time Frame: From baseline to 12 week, 1 year
To measure the change of quality of life status after stepwise psychopharmacotherapy or antidepressant monotherapy, EuroQol-5 Dimension is used. This scale has five descriptive questions which may have one of three-level answers and a visual analog scale (VAS) on which patients can mark their current health state. visual analog scale (VAS) on which patients can mark their current health state. The 5 Dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) have three levels of functioning each (no problems, some problems, and unable to/extreme problems) while the visual analog scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
From baseline to 12 week, 1 year
The changes of Social and Occupational Functioning Assessment Scale score
Time Frame: From baseline to 12 week
To measure the change of the social and occupational function after stepwise psychopharmacotherapy or antidepressant monotherapy, Social and Occupational Functioning Assessment Scale is used that ranges from 0 to 100, with lower scores representing lower functioning.
From baseline to 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Investigators

  • Principal Investigator: Jae-Min Kim, MD, PhD, Chonnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMDD-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant data (without individual identification data) will be translated into coded data and will be available from the principal investigator (J-M Kim) upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on antidepressant monotherapy group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe