Eye movements may reveal who benefits from depression medication
NCT ID NCT07723079
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tests whether eye-tracking can predict if the drug brexpiprazole will improve symptoms in adults with major depressive disorder. One participant will take brexpiprazole or placebo while researchers measure their visual attention to emotional images. The goal is to see if changes in eye patterns early in treatment can forecast clinical response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brexpiprazole as an add-on treatment
- What this could lead to
- If eye-tracking can predict who will respond to brexpiprazole, it could become a low-cost tool to guide depression treatment decisions.
- What could go wrong
- This is a single-person study, so results may not apply to others. The approach is still experimental and needs much larger trials to confirm.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1 person
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; * 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. Exclusion Criteria: * 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; * 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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital das Clínicas da faculdade de medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-000, Brazil
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