Psychopharmacotherapy for Depressive Patients

NCT06054321 | Recruiting

• 1 other identifier: BMDD-2022
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

depression; antidepressant monotherapy; stepwise psychopharmacotherapy; multimodal serum biomarker score

Outcome Measures

Primary Outcomes (1)

• Remission and treatment response status by Hamilton Depression Rating Scale

  Remission defined by total scores of Hamilton Depression Rating Scale (0-52; higher score indicates severe symptom) ≤7 and treatment response defined as ≥50% decrease in the baseline total scores of Hamilton Depression Rating Scale after stepwise psychopharmacotherapy or antidepressant monotherapy

  From baseline to 12 week, 1 year

Secondary Outcomes (7)

• The changes of Hamilton Rating Scale for Depression total score

  From baseline to 12 week, 1 year

• The changes of Hospital Anxiety and Depression Scale total score, depression subscore, anxiety subscore

  From baseline to 12 week, 1 year

• The changes of Clinical Global Impression-severity and improvement score

  From baseline to 12 week, 1 year

• The changes of Brief Psychiatric Rating Scale suicide item score

  From baseline to 12 week, 1 year

• The changes of EuroQol-5 Dimension score

  From baseline to 12 week, 1 year

Study Arms (4)

Good responder group-stepwise pharmacotherapy group

EXPERIMENTAL

Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then good responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group. 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: stepwise pharmacotherapy

Good responder group-antidepressant monotherapy group

ACTIVE COMPARATOR

Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then good responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group. In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.

Drug: antidepressant monotherapy group

Poor responder group-stepwise pharmacotherapy group

EXPERIMENTAL

Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then poor responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group. 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: stepwise pharmacotherapy

Poor responder group-antidepressant monotherapy group

ACTIVE COMPARATOR

Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then poor responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group. In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.

Drug: antidepressant monotherapy group

Interventions

stepwise pharmacotherapy DRUG

In the stepwise pharmacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.

Also known as: escitalopram, escitalopram with aripiprazole augmentation, escitalopram with lithium augmentation, escitalopram with mirtazapine combination

Good responder group-stepwise pharmacotherapy group; Poor responder group-stepwise pharmacotherapy group

antidepressant monotherapy group DRUG

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

Also known as: escitalopram monotherapy

Good responder group-antidepressant monotherapy group; Poor responder group-antidepressant monotherapy group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (1)

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jae-Min Kim, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae-Min Kim, MD, PhD

CONTACT

82-62-220-6043; jmkim@chonnam.ac.kr

Hee-Ju Kang, MD, PhD

CONTACT

82-62-220-5961; hjkang82@chonnam.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: partial masking(participants, care providers, outcome assessor are not aware of treatment response scores in spite of opened status for prescribed information (mono vs step)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: August 3, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)