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

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City (Other)

Overall Status

Recruiting

CT.gov ID

NCT04826614

Collaborator

(none)

188

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Other: optimized treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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