ADHDRx Meds GaizeNCT07389473
Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device
An observational study of ADHD and Depression Disorders, run by Gaize at 1 site in United States.
Trial summary
The study aims to verify if the Gaize ocular device can effectively identify eye movements indicative of prescribed psychotropic medication usage by employing Drug Recognition Expert (DRE) testing protocols within a controlled virtual environment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ADHD, Depression Disorders, Mood Disorders
- What is being tested?
- Prescription Psychotropic Medications
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to Aug 2028
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant population is limited to the city of Philadelphia, PA
Who may be able to join
- Adults aged between 18 and 65, having given written informed consent to participate in the research trial.
- Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months.
- Normal or corrected to normal vision using either glasses or contact lenses, or surgery.
Who cannot join
- Enrolled in, or participated in another clinical trial within 30 days before the study
- Having a prosthetic eye, missing eye, or wearer of an eye patch LASIK or other eye surgery within the prior 21 days.
- Had your eyes dilated by a medical doctor in the previous 24 hours.
- Photosensitive epilepsy
- Diagnosed with clinical blindness
- Medical Conditions: Participants with medical conditions or medications that could significantly affect cognitive and motor functions are excluded. Participants with conditions such as Glaucoma, macular degeneration, cataracts, lazy eye (amblyopia), or optic neuritis, or genetic anisocoria (unequal pupil size) will be excluded.
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- Current or past head inject/ traumatic brain injury (TBI)
- Pregnancy: Pregnant individuals will be excluded from the study due to the potential risks associated with psychiatric medications.
- History of Severe Motion Sickness: Participants with a history of severe motion sickness in VR environments may be excluded, as they may not tolerate the VR headset well.
- Potential participants who are unable to provide consent for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Apurva Raje Research Coordinator / Principal Investigator, BA contact
Rob Kaufmann CTO contact
United States1 site, 1 recruiting
- Recruiting
Gaize
Philadelphia, Pennsylvania, 19130
Apurva Raje Research Coordinator / Principal Investigator, 732-397-1795, apurva.raje@gaize.ai
About this study
Official title: An Observational Study to Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device
The study aims to verify if the Gaize ocular device can effectively identify eye movements indicative of prescribed psychotropic medication usage by employing Drug Recognition Expert (DRE) testing protocols within a controlled virtual environment.
Read the detailed description
The use of psychotropic (psychiatric) medications for various psychiatric disorders is a common practice. Long-term use of such medications necessitates monitoring due to potential side effects, including ophthalmic issues (1). The Gaize VR headset represents a novel approach to monitoring these effects by utilizing Drug Recognition Expert (DRE) testing methods to detect eye movements associated with substance use.
Psychotropic medications have been associated with a range of visual and oculomotor side effects, which can impact patient safety and quality of life (2). The prevalence of these effects in long-term users is not fully characterized in the literature, and traditional methods of assessment may miss subclinical alterations in eye movement or function. Eye movement patterns are altered predictably by the use of various substances, such as cannabis, alcohol, and other psychoactive drugs. DRE protocols utilize oculomotor tests to infer recent drug use (3). These protocols are, however, often subjective and require trained personnel to administer, leading to potential variability in assessment and risk of false positives. Advances in virtual reality technology have allowed for more precise and controlled assessment of eye movements. VR headsets can isolate and measure specific eye movement parameters, potentially providing a more accurate and objective measure of oculomotor function and impairment.
- Conditions
- ADHD, Depression Disorders, Mood Disorders, Anxiety Disorder Generalized, Bipolar Disorder (BPD)
- Being tested
- Prescription Psychotropic Medications
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Mood Disorders, Generalized Anxiety Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription Psychotropic MedicationsDrug
Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Participants will be recruited through local participants. Local psychiatrists will be enlisted to inform eligible patients about the research. Psychiatrists will disseminate information via study flyers displayed in their offices and through direct conversation with patients during appointments. This approach ensures informed and voluntary participation from individuals familiar with the psychiatric medication regimen, aligning with ethical research practices and privacy regulations. Potential participants' eligibility will be assessed based on predefined inclusion and exclusion criteria. If individuals meet these criteria and express interest, they will be provided with information about the study's objectives, potential risks, and benefits. Receives: Drug: Prescription Psychotropic Medications | |
| Control Group | We will recruit control group participants by posting up flyers to the general population through community bulletin boards, social media, and local community health centers. These participants will be matched to our patient group by age, sex, and other relevant demographic factors but will not be taking psychotropic medications. Interested individuals will undergo a screening process to ensure they meet the specific criteria for the control group. To maintain transparency and informed consent, all participants, both in the study and control groups, will receive consent forms. Those willing to participate will have the opportunity to review and sign these forms. Receives: Drug: Prescription Psychotropic Medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of Ophthalmic Data
Accuracy of the Gaize device in detecting eye-movement metrics consistent with prescribed psychotropic medication use, as determined by Drug Recognition Expert (DRE) testing protocols in a controlled virtual environment.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start17 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaize
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389473
- Sponsor's protocol ID
- 24-GPHPV-01
- Acronym
- Rx Meds Gaize
- Status last verified
- Feb 2026
- First submitted
- 20 Aug 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hartman RL, Richman JE, Hayes CE, Huestis MA. Drug Recognition Expert (DRE) examination characteristics of cannabis impairment. Accid Anal Prev. 2016 Jul;92:219-29. doi: 10.1016/j.aap.2016.04.012. Epub 2016 Apr 22.
PubMed 27107471Williams R, Hui A. Common systemic medications that every optometrist should know. Clin Exp Optom. 2022 Mar;105(2):149-156. doi: 10.1080/08164622.2021.1945409. Epub 2021 Aug 18.
PubMed 34407728Mahal P, Suthar N, Nebhinani N. Spotlight on Oculogyric Crisis: A Review. Indian J Psychol Med. 2021 Jan;43(1):5-9. doi: 10.1177/0253717620942096. Epub 2020 Sep 3.
PubMed 34349300
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device
- ClinicalTrials.gov ID
- NCT07389473
- Acronym / sponsor ID
- Rx Meds Gaize / 24-GPHPV-01
- Conditions
- ADHD, Depression Disorders, Mood Disorders, Anxiety Disorder Generalized, Bipolar Disorder (BPD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GaizeIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 5 Feb 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.
The study aims to verify if the Gaize ocular device can effectively identify eye movements indicative of prescribed psychotropic medication usage by employing Drug Recognition Expert (DRE) testing protocols within a controlled virtual environment.
Detailed description
The use of psychotropic (psychiatric) medications for various psychiatric disorders is a common practice. Long-term use of such medications necessitates monitoring due to potential side effects, including ophthalmic issues (1). The Gaize VR headset represents a novel approach to monitoring these effects by utilizing Drug Recognition Expert (DRE) testing methods to detect eye movements associated with substance use.
Psychotropic medications have been associated with a range of visual and oculomotor side effects, which can impact patient safety and quality of life (2). The prevalence of these effects in long-term users is not fully characterized in the literature, and traditional methods of assessment may miss subclinical alterations in eye movement or function. Eye movement patterns are altered predictably by the use of various substances, such as cannabis, alcohol, and other psychoactive drugs. DRE protocols utilize oculomotor tests to infer recent drug use (3). These protocols are, however, often subjective and require trained personnel to administer, leading to potential variability in assessment and risk of false positives. Advances in virtual reality technology have allowed for more precise and controlled assessment of eye movements. VR headsets can isolate and measure specific eye movement parameters, potentially providing a more accurate and objective measure of oculomotor function and impairment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Drug: Prescription Psychotropic MedicationsParticipants will be recruited through local participants. Local psychiatrists will be enlisted to inform eligible patients about the research. Psychiatrists will disseminate information via study flyers displayed in their offices and through direct conversation with patients during appointments. This approach ensures informed and voluntary participation from individuals familiar with the psychiatric medication regimen, aligning with ethical research practices and privacy regulations. Potential participants' eligibility will be assessed based on predefined inclusion and exclusion criteria. If individuals meet these criteria and express interest, they will be provided with information about the study's objectives, potential risks, and benefits. |
| Control Group | – | Drug: Prescription Psychotropic MedicationsWe will recruit control group participants by posting up flyers to the general population through community bulletin boards, social media, and local community health centers. These participants will be matched to our patient group by age, sex, and other relevant demographic factors but will not be taking psychotropic medications. Interested individuals will undergo a screening process to ensure they meet the specific criteria for the control group. To maintain transparency and informed consent, all participants, both in the study and control groups, will receive consent forms. Those willing to participate will have the opportunity to review and sign these forms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant population is limited to the city of Philadelphia, PA
Key inclusion criteria (3 listed)
- Adults aged between 18 and 65, having given written informed consent to participate in the research trial.
- Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months.
- Normal or corrected to normal vision using either glasses or contact lenses, or surgery.
Key exclusion criteria (10 listed)
- Enrolled in, or participated in another clinical trial within 30 days before the study
- Having a prosthetic eye, missing eye, or wearer of an eye patch LASIK or other eye surgery within the prior 21 days.
- Had your eyes dilated by a medical doctor in the previous 24 hours.
- Photosensitive epilepsy
- Diagnosed with clinical blindness
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 |
|---|---|---|
| Prescription Psychotropic MedicationsCurrently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months. | Drug | Control Group, Experimental Group |
Primary outcome
Collection of Ophthalmic Data
Time frame: 1 Day
Accuracy of the Gaize device in detecting eye-movement metrics consistent with prescribed psychotropic medication use, as determined by Drug Recognition Expert (DRE) testing protocols in a controlled virtual environment.
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 5 Feb 2026.
- Background: PubMed 27107471Hartman RL, Richman JE, Hayes CE, Huestis MA. Drug Recognition Expert (DRE) examination characteristics of cannabis impairment. Accid Anal Prev. 2016 Jul;92:219-29. doi: 10.1016/j.aap.2016.04.012. Epub 2016 Apr 22.
- Background: PubMed 34407728Williams R, Hui A. Common systemic medications that every optometrist should know. Clin Exp Optom. 2022 Mar;105(2):149-156. doi: 10.1080/08164622.2021.1945409. Epub 2021 Aug 18.
- Background: PubMed 34349300Mahal P, Suthar N, Nebhinani N. Spotlight on Oculogyric Crisis: A Review. Indian J Psychol Med. 2021 Jan;43(1):5-9. doi: 10.1177/0253717620942096. Epub 2020 Sep 3.
- Individual participant dataSharing planned: Undecided
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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.
Apurva Raje Research Coordinator / Principal Investigator, BA contact
Rob Kaufmann CTO contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD and Depression Disorders, run by Gaize at 1 site in United States.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 Feb 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 United States. 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?
Contact Apurva Raje Research Coordinator / Principal Investigator, BA (732-397-1795, apurva.raje@gaize.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of Ophthalmic Data (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07389473, which also lists 3 linked publications.
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 5 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.