Phase 3 PTSD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to read, understand, and sign a consent form agreeing to take part
• People aged 18 or older
• People who, in the past month, have experienced at least one of the following: nightmares or unwanted, intrusive thoughts; avoiding certain thoughts or situations; feeling constantly on edge, watchful, or easily startled; feeling numb or disconnected from people or surroundings; persistent feelings of guilt or self-blame; excessive worry on most days for at least 6 months about everyday things like work or school; trouble sleeping or restless sleep; feeling sad, empty, or hopeless most of the day nearly every day; loss of interest or pleasure in most activities nearly every day; significant changes in weight or appetite; sleeping too little or too much; noticeable restlessness or slowed movements; or feeling unusually tired or low in energy
• People the study team believes are likely to follow the study rules, including reporting any side effects, sharing mental health history, and attending all study visits
• People who agree to provide an emergency contact and share their location at each visit if joining remotely
• People the study doctor considers to be in a stable mental state
• People who have access to a device with a stable internet and Wi-Fi connection that supports video calls (such as a tablet or computer with a webcam), and also own an iPhone 13 or newer (not the iPhone 13 Mini) as a second device
• People whose home environment meets the setup requirements for the study's eye-tracking tool (for remote visits only)

Who may not be able to join:

• People with a current diagnosis of epilepsy or other seizure disorders
• People who have a history of, or are found to have at their first study visit, bipolar disorder (type I or II), mania, schizophrenia, schizoaffective disorder, delusional disorder, psychotic depression, or other psychotic conditions
• People with damage or impairment to the nerves or muscles around the eyes or face (for example, due to stroke, multiple sclerosis, or ALS)
• People currently diagnosed with dementia, delirium, memory disorders, autism, hydrocephalus, a condition causing the back of the brain to shrink, language disorders caused by brain damage, multiple sclerosis, or thinking and memory problems caused by stroke
• People with certain eye conditions that would prevent use of the study's eye-tracking tool, including: vision problems that cannot be corrected well enough to read; significant eyelid drooping that covers the pupil; persistent blurry vision, headaches, or light sensitivity from abnormal pupil responses; eye surgery within the past 2 weeks or planned during the study; inflammation inside the eye; or permanent uncorrected damage to both eyes from injury (note: glasses and standard contact lenses are allowed, but coloured or cosmetic lenses that affect the appearance of the pupil are not)
• People with active thoughts of harming themselves or others, or who score at the higher levels of suicidal thinking on a standard assessment tool used by the study team
• People who have made a suicide attempt within the past year, as identified at screening
• People who have had significant suicidal thoughts within the past 6 months, as identified at screening
• People who are currently using, or plan to use during the study, certain medications or substances that could affect the eye-tracking tool — including opioids/narcotics, certain older antidepressants (tricyclics), MAOIs, certain blood pressure medications, stimulants (such as amphetamines or cocaine — though caffeine and nicotine are not excluded), psychedelics, certain nerve-related medications, ketamine or Spravato, eye drops (unless able to stop use for more than 72 hours before the eye-tracking session), or certain sedatives such as benzodiazepines or barbiturates (confirm specific medications with the trial site)
• People currently using electrical brain stimulation therapies such as vagal nerve stimulation, deep brain stimulation, or transcranial magnetic stimulation
• People who have any condition that would make it difficult to safely complete questionnaires or follow the study's instructions, such as significant developmental disabilities, language disorders, or cognitive difficulties
• People who have been medically diagnosed with a traumatic brain injury within the past 12 months
• People with a lifetime history of brain surgery, brain infections (such as encephalitis or meningitis), degenerative brain diseases (such as Alzheimer's or Parkinson's disease), or any other condition, injury, or procedure the study doctor believes caused significant damage to the brain or nervous system
• People currently involved in legal proceedings related to their mental health symptoms
• People who are pregnant (based on self-report)
• People who are currently incarcerated
• People who require someone else to legally consent on their behalf
• People who have previously taken part in this study or another study using the same eye-tracking technology within the past 12 months
• People who, in the study doctor's opinion, are unwilling or unable to follow all study procedures

Important: Always verify eligibility with the trial site directly before applying.