Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Gaize
Study ID
NCT07389473
Status
Recruiting

Conditions

  • ADHD
  • Anxiety Disorder Generalized
  • Bipolar Disorder (BPD)
  • Depression Disorders
  • Mood Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Prescription Psychotropic Medications — DRUG
    Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months.

Study Details

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.

Key Dates

Start date
Apr 17, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Collection of Ophthalmic Data [ Time Frame: 1 Day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
GaizePhiladelphiaPennsylvania19130
Apurva Raje Research Coordinator / Principal Investigator
732-397-1795

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