Major Depressive DisorderNCT04826614
Comparing Efficacy of Optimal Treatment and Conventional Treatment for Major Depressive Disorder in Viet Nam
A study testing optimized treatment in people with Major Depressive Disorder, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- optimized treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Mar 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New or first recurrent diagnosed as major depression disorder.
- Having total score HAM-D 17 ≥ 17 point
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- optimized treatment
- Keywords
- Viet Nam, HAM-D, optimized treatment
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optimized treatmentOther
early adjust dose or change drug
| Study group | Role | What they receive |
|---|---|---|
| optimized treatment | Experimental | early adjust dose or change drug Receives: Other: optimized treatment |
| routine treatment | Active comparator | slowly adjust dose or change drug Receives: Other: optimized treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Mar 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Nguyen Thuy Phuong, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Dung V Do, Study director, Ho Chi Minh University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826614
- Sponsor's protocol ID
- LNTPhuong
- Status last verified
- Aug 2023
- First submitted
- 4 Jan 2020
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: age, sex
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Efficacy of Optimal Treatment and Conventional Treatment for Major Depressive Disorder in Viet Nam
- ClinicalTrials.gov ID
- NCT04826614
- Acronym / sponsor ID
- LNTPhuong
- Conditions
- Major Depressive Disorder
- Keywords
- Viet Nam, HAM-D, optimized treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optimized treatment | Experimental | Other: optimized treatmentearly adjust dose or change drug |
| routine treatment | Active comparator | Other: optimized treatmentslowly adjust dose or change drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- New or first recurrent diagnosed as major depression disorder.
- Having total score HAM-D 17 ≥ 17 point
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optimized treatmentearly adjust dose or change drug | Other | optimized treatment, routine treatment |
Primary outcome
Comparison of rate of respond patient between optimization and routine treatment group
Time frame: 8 weeks
Rate of responsers has HAMD-17 score decreases over 50 percent in each treatmennt group at each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No. age, sex
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dung V Do study director
Ho Chi Minh University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optimized treatment in people with Major Depressive Disorder, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of rate of respond patient between optimization and routine treatment group (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.