Psychopharmacotherapy for Depressive Patients

Major Depressive Disorder Clinical Trial

— BMDD-2022  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054321
• Other study ID #: BMDD-2022
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2022
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: Chonnam National University Hospital
• Contact: Jae-Min Kim, MD, PhD
• Phone: 82-62-220-6043
• Email: jmkim[@]chonnam.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.
• antidepressant monotherapy group
In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From baseline to 12 week, 1 year
Secondary	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	From baseline to 12 week, 1 year
Secondary	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.	From baseline to 12 week, 1 year
Secondary	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.	From baseline to 12 week, 1 year
Secondary	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.	From baseline to 12 week, 1 year
Secondary	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).	From baseline to 12 week, 1 year
Secondary	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.	From baseline to 12 week
Secondary	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	First dose of study drug to last dose of study drug in the 26-week Treatment Period and 1 year after baseline