Comparing two treatment approaches for major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.