Comparing two treatment approaches for major depressive disorder
A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients
NA · Chonnam National University Hospital · NCT06054321
This study is testing if a step-by-step approach to medication works better than a single antidepressant for adults with major depression over 12 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | Chonnam National University Hospital (other) |
| Locations | 1 site (Gwangju) |
| Trial ID | NCT06054321 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and tolerability of stepwise psychopharmacotherapy versus antidepressant monotherapy in adults with major depressive disorder over a 12-week period, followed by a one-year assessment. Participants will be stratified based on multimodal serum biomarker scores to predict treatment response and will be randomly assigned to one of the two treatment groups. The hypothesis suggests that while good responders will achieve remission regardless of the treatment modality, poor responders may benefit more from stepwise pharmacotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 65 diagnosed with major depressive disorder who have not recently started antidepressant treatment.
Not a fit: Patients with bipolar disorder, schizophrenia, or other severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with major depressive disorder.
How similar studies have performed: Previous studies have shown promise in personalized treatment approaches for depression, suggesting potential success for this study's methodology.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gwangju
- Chonnam National University Hospital — Gwangju, South Korea (RECRUITING)
Study contacts
- Principal investigator: Jae-Min Kim, MD, PhD — Chonnam National University Hospital
- Study coordinator: Jae-Min Kim, MD, PhD
- Email: jmkim@chonnam.ac.kr
- Phone: 82-62-220-6043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, depression, antidepressant monotherapy, stepwise psychopharmacotherapy, multimodal serum biomarker score