Major Depressive DisorderBMDD-2022NCT06054321
Psychopharmacotherapy for Depressive Patients
A study testing stepwise pharmacotherapy and antidepressant monotherapy group in people with Major Depressive Disorder, run by Chonnam National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- stepwise pharmacotherapy and antidepressant monotherapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2022to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chonnam National University Hospital
Gwangju, 61469
Young-Gwang Lee, CRC, 82-62-220-6152, gloryworld@nate.com
Jae-Min Kim, Md, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- stepwise pharmacotherapy, antidepressant monotherapy group
- Keywords
- depression, antidepressant monotherapy, stepwise psychopharmacotherapy, multimodal serum biomarker score
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stepwise pharmacotherapyDrug
Also called escitalopram, escitalopram with aripiprazole augmentation, escitalopram with lithium augmentation, escitalopram with mirtazapine combination
In the stepwise pharmacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.
antidepressant monotherapy groupDrug
Also called escitalopram monotherapy
In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Good responder group-stepwise pharmacotherapy group | Experimental | 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. Receives: Drug: stepwise pharmacotherapy |
| Good responder group-antidepressant monotherapy group | Active comparator | 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. Receives: Drug: antidepressant monotherapy group |
| Poor responder group-stepwise pharmacotherapy group | Experimental | 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. Receives: Drug: stepwise pharmacotherapy |
| Poor responder group-antidepressant monotherapy group | Active comparator | 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. Receives: Drug: antidepressant monotherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission and treatment response status by Hamilton Depression Rating Scale
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
Measured: From baseline to 12 week, 1 year
Secondary outcomes (7)
The changes of Hamilton Rating Scale for Depression total score
To measure the change of the severity of depressive symptoms using observer rating scale after stepwise psychopharmacotherapy or antidepressant monotherapy
Measured: From baseline to 12 week, 1 year
The changes of Hospital Anxiety and Depression Scale total score, depression subscore, anxiety subscore
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.
Measured: From baseline to 12 week, 1 year
The changes of Clinical Global Impression-severity and improvement score
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.
Measured: From baseline to 12 week, 1 year
The changes of Brief Psychiatric Rating Scale suicide item score
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.
Measured: From baseline to 12 week, 1 year
The changes of EuroQol-5 Dimension score
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).
Measured: From baseline to 12 week, 1 year
The changes of Social and Occupational Functioning Assessment Scale score
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.
Measured: From baseline to 12 week
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
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
Measured: First dose of study drug to last dose of study drug in the 26-week Treatment Period and 1 year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start3 Aug 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Min Kim, Chonnam National University Hospital
- Investigators
- Jae-Min Kim, MD, PhD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054321
- Sponsor's protocol ID
- BMDD-2022
- Acronym
- BMDD-2022
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Kim JM, Kang HJ, Kim JW, Jhon M, Choi W, Lee JY, Kim SW, Shin IS, Kim MG, Stewart R. Prospective associations of multimodal serum biomarkers with 12-week and 12-month remission in patients with depressive disorders receiving stepwise psychopharmacotherapy. Brain Behav Immun. 2022 Aug;104:65-73. doi: 10.1016/j.bbi.2022.05.012. Epub 2022 May 23.
PubMed 35618226
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients
- ClinicalTrials.gov ID
- NCT06054321
- Acronym / sponsor ID
- BMDD-2022 / BMDD-2022
- Conditions
- Major Depressive Disorder
- Keywords
- depression, antidepressant monotherapy, stepwise psychopharmacotherapy, multimodal serum biomarker score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Good responder group-stepwise pharmacotherapy group | Experimental | Drug: stepwise pharmacotherapyUsing 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. |
| Good responder group-antidepressant monotherapy group | Active comparator | Drug: antidepressant monotherapy groupUsing 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. |
| Poor responder group-stepwise pharmacotherapy group | Experimental | Drug: stepwise pharmacotherapyUsing 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. |
| Poor responder group-antidepressant monotherapy group | Active comparator | Drug: antidepressant monotherapy groupUsing 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stepwise pharmacotherapyAlso: escitalopram, escitalopram with aripiprazole augmentation, escitalopram with lithium augmentation, escitalopram with mirtazapine combinationIn the stepwise pharmacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks. | Drug | Good responder group-stepwise pharmacotherapy group, Poor responder group-stepwise pharmacotherapy group |
| antidepressant monotherapy groupAlso: escitalopram monotherapyIn the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks. | Drug | Good responder group-antidepressant monotherapy group, Poor responder group-antidepressant monotherapy group |
Primary outcome
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
7 secondary outcomes
The changes of Hamilton Rating Scale for Depression total score
Time frame: 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 changes of Clinical Global Impression-severity and improvement score
Time frame: 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
The changes of EuroQol-5 Dimension score
Time frame: From baseline to 12 week, 1 year
The changes of Social and Occupational Functioning Assessment Scale score
Time frame: From baseline to 12 week
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 35618226Kim JM, Kang HJ, Kim JW, Jhon M, Choi W, Lee JY, Kim SW, Shin IS, Kim MG, Stewart R. Prospective associations of multimodal serum biomarkers with 12-week and 12-month remission in patients with depressive disorders receiving stepwise psychopharmacotherapy. Brain Behav Immun. 2022 Aug;104:65-73. doi: 10.1016/j.bbi.2022.05.012. Epub 2022 May 23.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jae-Min Kim, MD, PhD principal investigator
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stepwise pharmacotherapy and antidepressant monotherapy group in people with Major Depressive Disorder, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jae-Min Kim, MD, PhD (82-62-220-6043, jmkim@chonnam.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission and treatment response status by Hamilton Depression Rating Scale (time frame: From baseline to 12 week, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06054321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.