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 — DRUGCurrently 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 GroupParticipants 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 GroupWe 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
- Apurva Raje Research Coordinator / Principal Investigator, BA732-397-1795
- Rob Kaufmann CTO
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Gaize | Philadelphia | Pennsylvania | 19130 |
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