Comparing Efficacy of Optimal Treatment and Conventional Treatment for Major Depressive Disorder in Viet Nam

Randomized Clinical Trial Comparing Efficacy of Optimal Treatment and Conventional Treatment for Major Depressive Disorder in Viet Nam

Comparison of efficacy treatment (respond, remission) between the optimized treatment group (dose adjustment or early change other drug based on the change of total score HAM-D 17) and the routine treatment group (start with the lowest effective dose and adjust dose slowly) for depressed patients in Viet Nam

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Other: optimized treatment

Detailed Description

Major depressive disorder (MDD) is a common with a lifetime prevalence about 16 %. MDD is able to be a recurrent and chronic condition. MDD is the second leading cause of disability worldwide. This disorder can reduce an individual's ability to perform at work or school to fulfill family responsibilities and to enjoy almost daily activities. Some evidences suggest that delay in treatment of MDD result in poorer outcome; longer time to remission is associated with residual symptoms, chronic condition, relapse and poorer recovery.

OBJECTIVE:

This study will compare effectiveness of the treatment by using measurement base care, accessing early improvement or lack of improvement to make decisions about regard to dose alteration, switching another antidepressant with standard treatment.

METHOD:

This study is the 8 week randomized controlled trial. Raters blind to protocol and 2 treatment group. This study conduct from March 2021 to March 2022 in UMC hospital, Ho Chi Minh city, Vietnam.

According to DSM criteria 5, 188 outpatient MDD will be recruited, 18-65 year-old, HAM D 17 ≥ 17 score. All patients will have ability to communicate and to provide the written consent. Exclusion criteria are psychotics, OCD, bipolar, suicide attempts in the current major depressive episode, unsuccessful suicide behavior 3 months ago, chronic another medical conditions (diabetes, hypothyroidism, pregnant, epilepsy, kidney failure, stroke, heart failure, liver failure, adrenal insufficiency)

The studied sample is divided into two groups:

Patients receiving standard treatment (group A):

Patients are treated with the minimally effective dose of an antidepressant which can be combined with other classes, for example, low dose antipsychotic medication, mirtazapine, zopiclone, benzodiazepine if insomnia is associated.

Patients are re-examined two times: after 4 weeks and 8 weeks of treatment to re-evaluate clinical symptoms. The current medication can be adjusted or even changed to another drug if it is necessary. This is decided by the assessment of the doctor at that moment.

The HAM-D 17 scale is used to access the patient three times: at the start of treatment, after 4 weeks, and 8 weeks of treatment by an autonomous researcher.

Patients have the right to stop participating in the study at any time and will be admitted to the hospital for treatment if there is a risk of suicide.

Group of patients receiving personalized and optimized treatment (group B):

HAM-D 17 scale is used to assessed patients at the initiation of treatment. Basing on clinical and severity on the HAMD-17 scale, doctors give the medication with the minimally or medium effective dose of an antidepressant corresponding to moderate or severe depression. The treatment can be combined with other groups of drugs such as antipsychotic drugs, mirtazapine, zopiclone, benzodiazepine if insomnia is included.

After 1 week of treatment, patients will be re-assessed with the HAM-D 17 scale. If there is no early improvement (decrease less than 20% of the initial score of HAM-D 17 scales), medication dose will be increased with a condition that the patient tolerates the drug and feel comfortable. Patients who cannot tolerate the current drug will be switched to another drug.

After 2 weeks of treatment, patients will be re-assessed with the HAM-D 17 scale. If there is still no early improvement (decrease less than 20% of the initial score of HAM-D 17 scales), medication dose will be increased again (to maximum dose) with a condition that the patient tolerates the drug and feel comfortable. Patients who cannot tolerate the current drug will be switched to another drug.

After 4 weeks of treatment, patients will be re-assessed with the HAM-D 17 scale. If a patient does not respond to the ongoing treatment (decrease less than 50% of the initial score of HAM-D 17 scales) with the maximum dose of the current antidepressant, he/she will be switch to another antidepressant After 6 weeks of treatment, patients will be re-assessed with the HAM-D 17 scale. If a patient still does not respond to the current treatment (decrease less than 50% of the initial score of HAM-D 17 scales), he/she will be switch to another antidepressant one more time.

After 8 week of treatment, patients will be re-assessed with the HAM-D 17 scale. Patients who do not respond to treatment or do not recover will continue to be treated and monitored in this outpatient clinic.

Patients have the right to stop participating in the study at any time and will be admitted to the hospital for treatment if there is a risk of suicide.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• New or first recurrent diagnosed as major depression disorder.
• Having total score HAM-D 17 ≥ 17 point

Exclusion Criteria:

• Can not answer the question in HAM-D 17
• Having psychosis, anxiety disorder, obsessive-compulsive disorder
• Having risk of suicide now or 3 months past
• having medical history: diabetes mellitus, hypothyroidism, hypopituitarism, epilepsy, renal failure, heart failure, stroke, myocardial infarction, liver failure, cirrhosis.
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: optimized treatment; early adjust dose or change drug	Other: optimized treatment; early adjust dose or change drug
Active Comparator: routine treatment; slowly adjust dose or change drug	Other: optimized treatment; early adjust dose or change drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of rate of respond patient between optimization and routine treatment group	Rate of responsers has HAMD-17 score decreases over 50 percent in each treatmennt group at each visit	8 weeks

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Investigators: Study Director: Dung V Do, Ho Chi Minh University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: January 4, 2020
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: HAM-D; Viet Nam; optimized treatment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: LNTPhuong

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: age, sex

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No