Psychopharmacotherapy for Depressive Patients
A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients
Chonnam National University Hospital
400 participants
Aug 3, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria12
- 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
Interventions
In the stepwise pharmacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.
In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06054321