Depression - Major Depressive Disorder3BD-TestNCT07269886
BIOMARKERS FOR DRUG SELECTION IN DEPRESSION
An observational study of Depression - Major Depressive Disorder, run by Neomente SAS at 1 site in Argentina.
Trial summary
The study aims to assess whether providing Clinical Decision Support Software (CDSS) information improves the pharmacological response in patients with depression. The CDSS integrates genomic, clinical, and blood biomarker data to assist psychiatrists in selecting the most appropriate treatment for each patient. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- How many people
- 79 participants
- Where
- 1 siteArgentina
- Study dates
- 18 Aug 2022to 30 Jun 2025
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Urban depressive outpatients from the City of Buenos Aires were recruited. The population of Buenos Aires is predominantly of Caucasian origin, mainly with ancestry from Italy and Spain.
Who may be able to join
- Being male or female, aged 18-65.
- Having a current DSM-5 diagnosis of non-psychotic Major Depressive Disorder confirmed by SCID.
- Having moderate to severe depressive symptoms as measured by the HAM-D-17.
- Being indicated for pharmacotherapy for Major Depressive Disorder.
- Providing written informed consent (signed and dated).
- -
Who cannot join
- Having a current or past diagnosis of bipolar disorder or psychotic disorders.
- Having a moderate to severe substance use disorder within the past six months.
- Having active suicidal ideation.
- Having a neurocognitive disorder.
- Having an unstable or decompensated medical illness likely to confound study outcomes.
- Being pregnant or lactating.
Show all 9Show fewer
- Having known contraindications to the indicated antidepressant classes.
- Being unable to provide informed consent.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BIOMARKERS FOR DRUG SELECTION IN DEPRESSION: 3BD Test
The study aims to assess whether providing Clinical Decision Support Software (CDSS) information improves the pharmacological response in patients with depression. The CDSS integrates genomic, clinical, and blood biomarker data to assist psychiatrists in selecting the most appropriate treatment for each patient.
A total of 72 patients diagnosed with Major Depressive Disorder were recruited. Participants were male and female adults aged 18 to 65 years, all presenting with moderate to severe symptomatology as assessed by the HAM-D-17 scale.
Read more
Enrolled patients were randomized into two groups:
- TAU group (Treatment as Usual) (+): patients received standard clinical care.
- CDSS group: psychiatrists received and could incorporate CDSS-generated information when making treatment decisions. (+) The TAU group received CDSS information at the 12-week follow-up.
All patients underwent blood collection at baseline (for blood-based and genomic biomarkers) and completed clinical evaluations at baseline, and at 8, 12, and 24 weeks of follow-up.
- Conditions
- Depression - Major Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| • TAU Group (Treatment as Usual): Patients were followed through standard clinical care. | Patients were evaluated at baseline by the treating physician and subsequently at weeks 8, 12, and 24 by an independent evaluator who was blinded to group allocation. The treating physicians of patients in the TAU group received the CDSS information after 12 weeks of follow-up. At that point, they also decided whether or not to consider the CDSS recommendations for pharmacological treatment decisions | |
| • CDSS Group (Clinical Decision Support Software): The treating physician received CDSS assistance | Psychiatrists received CDSS information and had the option to incorporate it into their treatment decisions starting at T0. Patients were assessed at baseline by the treating psychiatrist and subsequently at weeks 8, 12, and 24 by an independent evaluator who was blinded to group allocation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 8 in depressive symptoms assessed by HAM-D17
To evaluate improvement in depressive symptoms after 8 weeks of treatment in the TAU and CDSS groups, assessed by blinded evaluators using the HAM-D17. Change from baseline in HAM-D 17 total score at Week 8 was reported. The HAM-D 17 is a 17-item scale designed to measure the severity of depressive symptoms in participants. Each item reflects a core symptom of major depression. Items are rated on either a 3-point or 5-point scale, with higher scores indicating greater severity. The total score is the sum of all 17 item scores and ranges from 0 to 52, where higher scores indicate greater overall depressive symptom severity. A negative change in score indicates improvement.
Participant meets response criteria if there is at least a 50% reduction in the HAM-D17 total score from baseline to the last observation carried forward (LOCF) endpoint visit. A participant meets remission criteria if the HAMD-17 total score is less than or equal to 7 at the LOCF endpoint visit.
Measured: Changes from baseline to week 8
Secondary outcomes (2)
Change in Hamilton Depression Rating Scale-17 items (HAMD-17
The HAM-D 17 is a 17-item scale. Response is at least a 50% reduction in the 17-item HAM-D17 total score from baseline to the last observation carried forward (LOCF) endpoint visit. Remission is achieved when total score is less than or equal to 7 at the LOCF endpoint visit.
Measured: Changes from baseline to week 8 and week 12
Change in self-administered scale: Patient Health Questionnaire-9 (PHQ-9
PHQ-9 is a 9 item scale that ranges from 0 to 27 where higher scores indicate higher severity. Response is at least a 50% reduction in the total score from baseline to the LOCF endpoint visit. Remission is achieved when the total score is less than or equal to 4 at the LOCF endpoint visit.
Measured: Changes from baseline to week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start18 Aug 2022
- Primary completion16 Oct 2022
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Neomente SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269886
- Sponsor's protocol ID
- Neomente
- Acronym
- 3BD-Test
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOMARKERS FOR DRUG SELECTION IN DEPRESSION: 3BD Test
- ClinicalTrials.gov ID
- NCT07269886
- Acronym / sponsor ID
- 3BD-Test / Neomente
- Conditions
- Depression - Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Neomente SASIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 16 Oct 2022 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 8 Dec 2025 (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.
The study aims to assess whether providing Clinical Decision Support Software (CDSS) information improves the pharmacological response in patients with depression. The CDSS integrates genomic, clinical, and blood biomarker data to assist psychiatrists in selecting the most appropriate treatment for each patient.
A total of 72 patients diagnosed with Major Depressive Disorder were recruited. Participants were male and female adults aged 18 to 65 years, all presenting with moderate to severe symptomatology as assessed by the HAM-D-17 scale.
Enrolled patients were randomized into two groups:
- TAU group (Treatment as Usual) (+): patients received standard clinical care.
- CDSS group: psychiatrists received and could incorporate CDSS-generated information when making treatment decisions. (+) The TAU group received CDSS information at the 12-week follow-up.
All patients underwent blood collection at baseline (for blood-based and genomic biomarkers) and completed clinical evaluations at baseline, and at 8, 12, and 24 weeks of follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • TAU Group (Treatment as Usual): Patients were followed through standard clinical care. | – | –Patients were evaluated at baseline by the treating physician and subsequently at weeks 8, 12, and 24 by an independent evaluator who was blinded to group allocation. The treating physicians of patients in the TAU group received the CDSS information after 12 weeks of follow-up. At that point, they also decided whether or not to consider the CDSS recommendations for pharmacological treatment decisions |
| • CDSS Group (Clinical Decision Support Software): The treating physician received CDSS assistance | – | –Psychiatrists received CDSS information and had the option to incorporate it into their treatment decisions starting at T0. Patients were assessed at baseline by the treating psychiatrist and subsequently at weeks 8, 12, and 24 by an independent evaluator who was blinded to group allocation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urban depressive outpatients from the City of Buenos Aires were recruited. The population of Buenos Aires is predominantly of Caucasian origin, mainly with ancestry from Italy and Spain.
Key inclusion criteria (6 listed)
- Being male or female, aged 18-65.
- Having a current DSM-5 diagnosis of non-psychotic Major Depressive Disorder confirmed by SCID.
- Having moderate to severe depressive symptoms as measured by the HAM-D-17.
- Being indicated for pharmacotherapy for Major Depressive Disorder.
- Providing written informed consent (signed and dated).
Key exclusion criteria (9 listed)
- Having a current or past diagnosis of bipolar disorder or psychotic disorders.
- Having a moderate to severe substance use disorder within the past six months.
- Having active suicidal ideation.
- Having a neurocognitive disorder.
- Having an unstable or decompensated medical illness likely to confound study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline to week 8 in depressive symptoms assessed by HAM-D17
Time frame: Changes from baseline to week 8
To evaluate improvement in depressive symptoms after 8 weeks of treatment in the TAU and CDSS groups, assessed by blinded evaluators using the HAM-D17. Change from baseline in HAM-D 17 total score at Week 8 was reported. The HAM-D 17 is a 17-item scale designed to measure the severity of depressive symptoms in participants. Each item reflects a core symptom of major depression. Items are rated on either a 3-point or 5-point scale, with higher scores indicating greater severity. The total score is the sum of all 17 item scores and ranges from 0 to 52, where higher scores indicate greater overall depressive symptom severity. A negative change in score indicates improvement. Participant meets response criteria if there is at least a 50% reduction in the HAM-D17 total score from baseline to the last observation carried forward (LOCF) endpoint visit. A participant meets remission criteria if the HAMD-17 total score is less than or equal to 7 at the LOCF endpoint visit.
2 secondary outcomes
Change in Hamilton Depression Rating Scale-17 items (HAMD-17
Time frame: Changes from baseline to week 8 and week 12
Change in self-administered scale: Patient Health Questionnaire-9 (PHQ-9
Time frame: Changes from baseline to week 8 and week 12
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 8 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder, run by Neomente SAS at 1 site in Argentina.
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 6 inclusion and 9 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 8 Dec 2025. 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 Argentina. 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?
Change from baseline to week 8 in depressive symptoms assessed by HAM-D17 (time frame: Changes from baseline to week 8). 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 8 Dec 2025.