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Single-case Intervention Study for Visual Screening Assessment for Proof of Concept and Prediction of Clinical Response to Brexiprazole as Adjunctive Treatment in Adults With Major Depressive Disorder.

NCT07723079 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-07-23

No results posted yet for this study

Summary

Major Depressive Disorder (MDD) is the most prevalent mental disorder in the world, with high rates of recurrence and dysfunction. A significant portion of patients do not respond adequately to conventional treatments, highlighting the need to search for biomarkers capable of predicting clinical response.

A relevant marker in depression is attentional bias, which is characterized by the preferential processing of negative stimuli, and is inferred as a useful tool in the diagnosis and treatment of depression. The best way to measure attentional bias is through eye-tracking.

In a smaller body of evidence, it is indicated that pharmacological treatment of depression is able to modify the visual tracking pattern, directing it towards a tendency towards normalization when compared to healthy controls, and that this precedes the clinical response.

The study proposes a single-case, blinded design conducted at the Institute of Psychiatry of the HC-FMUSP to evaluate whether visual tracking patterns obtained by eye-tracking in the first weeks of treatment with brexpiprazole (1 and 2 mg/day) as an adjunct in adults with MDD are able to predict clinical response when compared to placebo.

The primary outcome will be measured by the MADRS questionnaire and the secondary outcome by the Clinical Global Impression (CGI). The eye-tracking assessment will use the Tobii eye-tracker 250 Hz device, with images from the International Affective Picture System (IAPS), and will be performed weekly over 10 weeks. It is expected to establish eye-tracking as a low-cost tool to assist in predicting therapeutic response in depression.

Conditions

  • Depression - Major Depressive Disorder

Interventions

DEVICE

Eyetracking (Tobii Pro Fusion 250 hz)

Intervention with brexpiprazole in paciente with depression

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Hermano Tavares · Professor associate

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-06-01
Completion
2026-08-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07723079 on ClinicalTrials.gov