BIOMARKERS FOR DRUG SELECTION IN DEPRESSION

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.

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Key information

Conditions

Depression - Major Depressive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Neomente

Buenos Aires, 1425, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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.
Having known contraindications to the indicated antidepressant classes.
Being unable to provide informed consent.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Change in Hamilton Depression Rating Scale-17 items (HAMD-17

Time frame: Changes from baseline to week 8 and week 12

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.
Change in self-administered scale: Patient Health Questionnaire-9 (PHQ-9

Time frame: Changes from baseline to week 8 and week 12

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.

Sponsors and collaborators

Lead sponsor

Neomente SAS

Industry

Registry information

Official study title

BIOMARKERS FOR DRUG SELECTION IN DEPRESSION: 3BD Test

Acronym: 3BD-Test

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2025
First posted: Dec 8, 2025
Registry last updated: Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed