BIOMARKERS FOR DRUG SELECTION IN DEPRESSION

NCT ID: NCT07269886

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-18
• Study Completion Date: 2025-06-30

Brief 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.

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.

Conditions

Depression - Major Depressive Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

• 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.

No interventions assigned to this group

• 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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Being male or female, aged 18-65.

2. Having a current DSM-5 diagnosis of non-psychotic Major Depressive Disorder confirmed by SCID.

3. Having moderate to severe depressive symptoms as measured by the HAM-D-17.

4. Being indicated for pharmacotherapy for Major Depressive Disorder.

5. Providing written informed consent (signed and dated).

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Exclusion Criteria

1. Having a current or past diagnosis of bipolar disorder or psychotic disorders.

2. Having a moderate to severe substance use disorder within the past six months.

3. Having active suicidal ideation.

4. Having a neurocognitive disorder.

5. Having an unstable or decompensated medical illness likely to confound study outcomes.

6. Being pregnant or lactating.

7. Having known contraindications to the indicated antidepressant classes.

8. Being unable to provide informed consent.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neomente SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Neomente

Buenos Aires, , Argentina

Countries

Argentina

Other Identifiers

Neomente

Identifier Type: -

Identifier Source: org_study_id