Clinical trial NCT06054321: Psychopharmacotherapy for Depressive Patients
Official title: A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
antidepressant monotherapy
stepwise psychopharmacotherapy
multimodal serum biomarker score
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Remission and treatment response status by Hamilton Depression Rating Scale
timeFrame: From baseline to 12 week, 1 year
Secondary outcomes:
measure: The changes of Hamilton Rating Scale for Depression total score
timeFrame: From baseline to 12 week, 1 year
measure: The changes of Hospital Anxiety and Depression Scale total score, depression subscore, anxiety subscore
timeFrame: From baseline to 12 week, 1 year
measure: The changes of Clinical Global Impression-severity and improvement score
timeFrame: From baseline to 12 week, 1 year
measure: The changes of Brief Psychiatric Rating Scale suicide item score
timeFrame: From baseline to 12 week, 1 year
measure: The changes of EuroQol-5 Dimension score
timeFrame: From baseline to 12 week, 1 year
measure: The changes of Social and Occupational Functioning Assessment Scale score
timeFrame: From baseline to 12 week
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
timeFrame: First dose of study drug to last dose of study drug in the 26-week Treatment Period and 1 year after baseline
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Jae-Min Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.