Psychopharmacotherapy for Depressive Patients

Официальное название

A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат antidepressant monotherapy group
  In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.

Первичные конечные точки

• Remission and treatment response status by Hamilton Depression Rating Scale [Срок оценки: From baseline to 12 week, 1 year]

Вторичные конечные точки (7)

• The changes of Hamilton Rating Scale for Depression total score [Срок оценки: From baseline to 12 week, 1 year]
• The changes of Hospital Anxiety and Depression Scale total score, depression subscore, anxiety subscore [Срок оценки: From baseline to 12 week, 1 year]
• The changes of Clinical Global Impression-severity and improvement score [Срок оценки: From baseline to 12 week, 1 year]
• The changes of Brief Psychiatric Rating Scale suicide item score [Срок оценки: From baseline to 12 week, 1 year]
• The changes of EuroQol-5 Dimension score [Срок оценки: From baseline to 12 week, 1 year]
• The changes of Social and Occupational Functioning Assessment Scale score [Срок оценки: From baseline to 12 week]
• Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period [Срок оценки: First dose of study drug to last dose of study drug in the 26-week Treatment Period and 1 year after baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Chonnam National University Hospital — Gwangju

Публикации

• 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

Идентификаторы

NCT: NCT06054321 · BMDD-2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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