Recruiting

Gaize Ocular Device

Sponsor:

Gaize

Code:

NCT07389473

Conditions

ADHD

Depression Disorders

Mood Disorders

Anxiety Disorder Generalized

Bipolar Disorder (BPD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Prescription Psychotropic Medications

Study Details

Brief 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.

Conditions

ADHD

Depression Disorders

Mood Disorders

Anxiety Disorder Generalized

Bipolar Disorder (BPD)

Study ID

NCT07389473

Start date

Apr 17, 2024

Status verified date

Feb, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Prescription Psychotropic Medications

Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months.

Primary outcome measure

  • Collection of Ophthalmic Data [ Time Frame: 1 Day ]

Central Contacts and Locations

Central contacts

Apurva Raje Research Coordinator / Principal Investigator, BA

732-397-1795apurva.raje@gaize.ai

Rob Kaufmann CTO

rob.kaufmann@gaize.ai

Locations

Gaize

Recruiting

Philadelphia, Pennsylvania, United States, 19130

Contacts

Apurva Raje Research Coordinator / Principal Investigator

732-397-1795apurva.raje@gaize.ai

More Information

Sponsor

Gaize

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Gaize on 2026-02-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.