Back to resultsA Randomized Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depression (BMDD-2022)
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
stepwise pharamacotherapy
antidepressant monotherapy group
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, antidepressant monotherapy, stepwise psychopharmacotherapy, multimodal serum biomarker score
Eligibility Criteria
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
Sites / Locations
- Chonnam National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Good responder group-stepwise pharamacotherapy group
Good responder group-antidepressant monotherapy group
Poor responder group-stepwise pharamacotherapy group
Poor responder group-antidepressant monotherapy group
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Remission and treatment response status by Hamilton Depression Rating Scale (HRDS) ≤7
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
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
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
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
To measure the change of the suicidal-related severity after stepwise psychopharmacotherapy or antidepressant monotherapy
The changes of Sheehan Disability Scale score
To measure the change of the functional disability after stepwise psychopharmacotherapy or antidepressant monotherapy
The changes of EuroQol-5D score
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
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
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
Full Information
NCT ID
NCT06054321
First Posted
September 19, 2023
Last Updated
September 19, 2023
Sponsor
Chonnam National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06054321
Brief Title
A Randomized Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depression
Acronym
BMDD-2022
Official Title
A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, antidepressant monotherapy, stepwise psychopharmacotherapy, multimodal serum biomarker score
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes 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)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Good responder group-stepwise pharamacotherapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Good responder group-antidepressant monotherapy group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Poor responder group-stepwise pharamacotherapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Poor responder group-antidepressant monotherapy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
stepwise pharamacotherapy
Other Intervention Name(s)
escitalopram, escitalopram with aripiprazole augementation, escitalopram with lithium augumentation, escitalopram with mirtazapine combination
Intervention Description
In the stepwise pharamacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
antidepressant monotherapy group
Other Intervention Name(s)
escitalopram monotherapy
Intervention Description
In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.
Primary Outcome Measure Information:
Title
Remission and treatment response status by Hamilton Depression Rating Scale (HRDS) ≤7
Description
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
Time Frame
From baseline to 12 week, 1 year
Secondary Outcome Measure Information:
Title
The changes of Hamilton Rating Scale for Depression (HAMD) total score
Description
To measure the change of the severity of depressive symptoms using observer rating scale after stepwise psychopharmacotherapy or antidepressant monotherapy
Time Frame
From baseline to 12 week, 1 year
Title
The changes of Hospital Anxiety and Depression Scale (HADS) total score, depression subscore, anxiety subscore
Description
To measure the change of the severity of depressive symptoms using self-reported scale after stepwise psychopharmacotherapy or antidepressant monotherapy
Time Frame
From baseline to 12 week, 1 year
Title
The changes of Clinical Global Impression (CGI)-severity and improvement score
Description
To measure the change of the global severity and improvement of depressive symptoms after stepwise psychopharmacotherapy or antidepressant monotherapy
Time Frame
From baseline to 12 week, 1 year
Title
The changes of Brief Psychiatric Rating Scale(BPRS) suicide item score
Description
To measure the change of the suicidal-related severity after stepwise psychopharmacotherapy or antidepressant monotherapy
Time Frame
From baseline to 12 week, 1 year
Title
The changes of Sheehan Disability Scale score
Description
To measure the change of the functional disability after stepwise psychopharmacotherapy or antidepressant monotherapy
Time Frame
From baseline to 12 week, 1 year
Title
The changes of EuroQol-5D score
Description
To measure the change of quality of life status after stepwise psychopharmacotherapy or antidepressant monotherapy
Time Frame
From baseline to 12 week, 1 year
Title
The changes of Social and Occupational Functioning Assessment Scale score
Description
To measure the change of the social and occupational function after stepwise psychopharmacotherapy or antidepressant monotherapy
Time Frame
From baseline to 12 week
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
Description
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
Time Frame
First dose of study drug to last dose of study drug in the 26-week Treatment Period and 1 year after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Min Kim, MD, PhD
Phone
82-62-220-6043
Email
jmkim@chonnam.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hee-Ju Kang, MD, PhD
Phone
82-62-220-5961
Email
hjkang82@chonnam.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Min Kim, MD, PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Gwang Lee, CRC
Phone
82-62-220-6152
Email
gloryworld@nate.com
First Name & Middle Initial & Last Name & Degree
Jae-Min Kim, Md, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The participant data without individual identification data that is translated into coded data are available from the principal investigator (J-M Kim) upon reasonable request
Citations:
PubMed Identifier
35618226
Citation
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.
Results Reference
background
Learn more about this trial
A Randomized Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depression
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