Recruiting
Psychopharmacotherapy for 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.
ClinicalTrials.gov IDNCT06054321
PhaseNA
Enrollment400
SponsorChonnam National University Hospital
Age19 Years
SexALL
Conditions studied
Major Depressive Disorder
About this study
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.
Interventions
- 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.
- Drug: antidepressant monotherapy group — In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.
Primary outcomes
- Remission and treatment response status by Hamilton Depression Rating Scale (From baseline to 12 week, 1 year)
Eligibility information
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 locations
- Chonnam National University Hospital, Gwangju, 61469 South Korea
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.