Psychopharmacotherapy for Depressive Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: stepwise pharmacotherapy, antidepressant monotherapy group.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder. Basic parameters: 19 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients
Overview
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.
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 outcome measures
- Remission and treatment response status by Hamilton Depression Rating Scale [Time frame: From baseline to 12 week, 1 year]
Secondary outcome measures (7)
- The changes of Hamilton Rating Scale for Depression total score [Time frame: From baseline to 12 week, 1 year]
- The changes of Hospital Anxiety and Depression Scale total score, depression subscore, anxiety subscore [Time frame: From baseline to 12 week, 1 year]
- The changes of Clinical Global Impression-severity and improvement score [Time frame: From baseline to 12 week, 1 year]
- The changes of Brief Psychiatric Rating Scale suicide item score [Time frame: From baseline to 12 week, 1 year]
- The changes of EuroQol-5 Dimension score [Time frame: From baseline to 12 week, 1 year]
- The changes of Social and Occupational Functioning Assessment Scale score [Time frame: From baseline to 12 week]
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period [Time frame: First dose of study drug to last dose of study drug in the 26-week Treatment Period and 1 year after baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Chonnam National University Hospital — Gwangju
Publications
- 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. PMID 35618226
Identifiers
NCT: NCT06054321 · BMDD-2022