Depression - Major Depressive DisorderETBREXNCT07723079
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.
A study testing Eyetracking (Tobii Pro Fusion 250 hz) in people with Depression - Major Depressive Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Eyetracking (Tobii Pro Fusion 250 hz)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be initially assessed through a clinical interview by a specialized psychiatrist and subsequently by a second interviewer who will use the eligibility criteria and screening and diagnostic confirmation instruments below to delineate the sample universe, and must meet the following criteria before randomization:
- Diagnosis of MDD, in a single or recurrent, non-psychotic episode, as defined by the DSM-IV-TR through specialized clinical evaluation and confirmed by the Mini International Neuropsychiatric Interview (MINI - Amorim, 2000);
- The current depressive episode must have a duration of ≥ 8 weeks;
- Inadequate response to ≤ 2 attempts at pharmacological treatment for the current episode of MDD, including the treatment the patient is undergoing at the time of screening, with each attempt lasting a minimum of 4 to 6 weeks, with a first-line antidepressant (SSRI or SNRI) and with a minimum effective dose (defined by the package insert) or higher;
- Inadequate response is defined as: < 50% reduction in the severity of depressive symptoms, as measured by the subject's self-report score on the Visual Analogue Scale (VAS);
- Be between 18 and 60 years of age, inclusive;
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- Have a score ≥ 24 on the Montgomery-Åsberg Depression Scale (MADRS);
- Have read and signed the informed consent form (Appendix 1) after the nature of the study has been fully explained and before any study-related procedures are performed;
- Female patients must be:
- Postmenopausal for at least one year, or;
- Surgically unable to conceive (having undergone hysterectomy or bilateral oophorectomy or tubal ligation or otherwise unable to conceive), or;
- Practicing an acceptable method of birth control (defined as: hormonal contraceptives, spermicide plus barrier, a single vasectomized partner and/or intrauterine device);
- If a potentially pregnant patient is practicing an acceptable method of birth control (as mentioned above), she must have a negative urine pregnancy test at enrollment, as well as at baseline, before receiving the study drug.
Who cannot join
- Potential patients who meet any of the following criteria will be prohibited from participating in the study:
- Known contraindication to brexpiprazole or known hypersensitivity;
- Individuals who report treatment with adjunctive antipsychotic medication to an antidepressant during the current major depressive episode;
- Individuals who have a history of ECT (electroconvulsive therapy) treatment at any time in the past or present, or who have received vagus nerve stimulation or an implanted deep brain stimulation device for the treatment of treatment-resistant depression;
- Individuals currently requiring hospitalization or who have been hospitalized in the four weeks prior to screening for the current major depressive episode;
- Exposure to any other experimental drug or device in the 30 days prior to inclusion, except for previously described antidepressant use;
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- Use of benzodiazepines and/or hypnotics (including non-benzodiazepine inducers) within 1 week prior to the start of the study, but excluding short-acting non-benzodiazepine sleep inducers (i.e., zolpidem, zaleplon, zopiclone, and eszopiclone only);
- Pregnancy, breastfeeding, or patients intending to become pregnant during the study;
- Evidence of renal impairment, defined as serum creatinine levels > 133 mmol/L in men, > 124 mmol/L in women, which correspond to > 1.51 mg/dL and > 1.41 mg/dL, respectively, at Week 1 of inclusion;
- Evidence of clinically significant hepatic impairment (defined as AST or ALT > 2 times the upper limit of normal) at Week 1 of inclusion;
- Significant cardiovascular disease, including a history of myocardial infarction in the last 5 years, stroke, clinically significant valvular heart disease, unstable angina, clinically abnormal ECG, arrhythmia, or congestive heart failure, resulting in cardiovascular disability functional class III or IV (NYHA, 1964);
- Uncontrolled hypertension (defined as a diastolic blood pressure ≥ 100 mmHg and/or a systolic blood pressure ≥ 180 mmHg with or without medication).
- Hypertensive patients receiving medication must have been receiving the same dose of the same antihypertensive medication for at least two months;
- -Evidence of uncontrolled thyroid disorders, including hyper- or hypothyroidism or abnormal TSH levels. Patients known to be on thyroid hormone replacement therapy must have been on a stable dose for at least three months prior to inclusion and have a normal TSH level at inclusion;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da faculdade de medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-000
About this study
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.
Read more
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
- Being tested
- Eyetracking (Tobii Pro Fusion 250 hz)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyetracking (Tobii Pro Fusion 250 hz)Device
Also called Brexpiprazole
Intervention with brexpiprazole in paciente with depression
| Study group | Role | What they receive |
|---|---|---|
| Brexipirazole Treatment + Eye-Tracking Assessment(Tobii Pro Fusion 250 hz) | Experimental | Participant with depression disorder will undergo baseline eye-tracking (Tobii Pro Fusion 250 hz)assessment followed by treatment with brexipiprazole. Eye-tracking (Tobii Pro Fusion 250 hz) data will be used to evaluate its predictive value for clinical response to pharmacological treatment. Receives: Device: Eyetracking (Tobii Pro Fusion 250 hz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between baseline eye-tracking measures and clinical response to naltrexone
Predictive accuracy of baseline eye-tracking metrics for clinical response to naltrexone treatment in individuals with gaming disorder
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Apr 2026
- Primary completion1 Jun 2026
- Study completion1 Aug 2026 (estimated)
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.
- More trials run by University of Sao PauloThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermano Tavares, University of Sao Paulo
- Investigators
- Hermano Tavares, Principal investigator, Professor associate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723079
- Sponsor's protocol ID
- Depression Brexpiprazole
- Acronym
- ETBREX
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07723079
- Acronym / sponsor ID
- ETBREX / Depression Brexpiprazole
- Conditions
- Depression - Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 23 Jul 2026 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brexipirazole Treatment + Eye-Tracking Assessment(Tobii Pro Fusion 250 hz) | Experimental | Device: Eyetracking (Tobii Pro Fusion 250 hz)Participant with depression disorder will undergo baseline eye-tracking (Tobii Pro Fusion 250 hz)assessment followed by treatment with brexipiprazole. Eye-tracking (Tobii Pro Fusion 250 hz) data will be used to evaluate its predictive value for clinical response to pharmacological treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Patients will be initially assessed through a clinical interview by a specialized psychiatrist and subsequently by a second interviewer who will use the eligibility criteria and screening and diagnostic confirmation instruments below to delineate the sample universe, and must meet the following criteria before randomization:
- Diagnosis of MDD, in a single or recurrent, non-psychotic episode, as defined by the DSM-IV-TR through specialized clinical evaluation and confirmed by the Mini International Neuropsychiatric Interview (MINI - Amorim, 2000);
- The current depressive episode must have a duration of ≥ 8 weeks;
- Inadequate response to ≤ 2 attempts at pharmacological treatment for the current episode of MDD, including the treatment the patient is undergoing at the time of screening, with each attempt lasting a minimum of 4 to 6 weeks, with a first-line antidepressant (SSRI or SNRI) and with a minimum effective dose (defined by the package insert) or higher;
- Inadequate response is defined as: < 50% reduction in the severity of depressive symptoms, as measured by the subject's self-report score on the Visual Analogue Scale (VAS);
Key exclusion criteria (14 listed)
- Potential patients who meet any of the following criteria will be prohibited from participating in the study:
- Known contraindication to brexpiprazole or known hypersensitivity;
- Individuals who report treatment with adjunctive antipsychotic medication to an antidepressant during the current major depressive episode;
- Individuals who have a history of ECT (electroconvulsive therapy) treatment at any time in the past or present, or who have received vagus nerve stimulation or an implanted deep brain stimulation device for the treatment of treatment-resistant depression;
- Individuals currently requiring hospitalization or who have been hospitalized in the four weeks prior to screening for the current major depressive episode;
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 |
|---|---|---|
| Eyetracking (Tobii Pro Fusion 250 hz)Also: BrexpiprazoleIntervention with brexpiprazole in paciente with depression | Device | Brexipirazole Treatment + Eye-Tracking Assessment(Tobii Pro Fusion 250 hz) |
Primary outcome
Association between baseline eye-tracking measures and clinical response to naltrexone
Time frame: Baseline to Week 8
Predictive accuracy of baseline eye-tracking metrics for clinical response to naltrexone treatment in individuals with gaming disorder
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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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.
Hermano Tavares principal investigator
Professor associate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyetracking (Tobii Pro Fusion 250 hz) in people with Depression - Major Depressive Disorder, run by University of Sao Paulo at 1 site in Brazil.
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 13 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
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?
Association between baseline eye-tracking measures and clinical response to naltrexone (time frame: 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 23 Jul 2026.