Eye-Tracking study seeks to unlock secrets of bipolar brain

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Inclusion and Exclusion Criteria for Group 1: bipolar disorder without current anxiety or substance use disorder 1. Inclusion Criteria for Group 1: i. Male or female, age 18 or older ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to Diagnostic and Statistical Manual-5 (DSM-5) criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI) iii. Currently in a depressive episode or currently in remission from a mood episode iv. Young Mania Rating Scale total score ≤ 8 v. In the opinion of the investigator, capable of understanding and complying with protocol requirements vi. In the opinion of the investigator, has the competency to understand and sign the informed consent vii. Subject is compliant with taking psychiatric medication(s) per the investigator's discretion b. Exclusion Criteria for Group 1: i. Significant structural brain lesion (e.g. infarct, hemorrhage, tumor, multiple sclerosis) ii. Progressive neurological disease such as neurodegenerative disease iii. Any current psychiatric disorder (other than a current depressive episode) including anxiety disorders, substance use disorders, antisocial personality disorder and borderline personality disorder as assessed by the MINI and clinician assessment. iv. Currently pregnant or planning to become pregnant v. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription vi. Currently taking any steroids, stimulants, or opioid pain killers. vii. Meets DSM-5 criteria for any alcohol and/or drug use disorder within the last 6 months, excluding the use of caffeine.Currently experiencing nicotine use disorder or any smoking of cigarettes or use of other nicotine containing products within a week before the eye tracking visit. viii. Has had electroconvulsive therapy (ECT) treatment within the last 6 months. 2. Inclusion and Exclusion Criteria for Group 2: Bipolar disorder with a current anxiety disorder (generalized anxiety disorder, panic disorder, and/or social phobia) a. Inclusion Criteria for Group 2: i. Male or female, age 18 or older ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to DSM-5 criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI) iii. Currently in a depressive episode or currently in remission from a mood episode iv. Meets diagnostic criteria for a current anxiety disorder (generalized anxiety disorder, panic disorder, and/or social phobia) as confirmed by the Mini International Neuropsychiatric Interview (MINI) v. Hamilton Anxiety Rating Scale total score ≥ 18 vi. Young Mania Rating Scale total score ≤ 8 vii. In the opinion of the investigator, capable of understanding and complying with protocol requirements viii. In the opinion of the investigator, has the competency to understand and sign the informed consent ix. Subject is compliant with taking psychiatric medication(s) per the investigator's discretion b. Exclusion Criteria for Group 2: i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis) ii. Progressive neurological disease such as neurodegenerative disease iii. Any co-occurring lifetime or current obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), or attention deficit hyperactivity disorder (ADHD) iv. Meets criteria for antisocial personality disorder or borderline personality disorder as assessed by clinician assessment. v. Currently pregnant or planning to become pregnant vi. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription vii. Currently taking any steroids, stimulants, or opioid pain killers. viii. Meets DSM-5 criteria for any alcohol and/or drug use disorder within the last 6 months, excluding the use of caffeine ix. Currently experiencing nicotine use disorder or any smoking of cigarettes or use of other nicotine containing products within a week before the eye tracking visit. x. Has had ECT treatment within the last 6 months. 3. Inclusion and Exclusion Criteria for Group 3: Bipolar disorder with a current anxiety disorder and a current substance use disorder a. Inclusion Criteria for Group 3: i. Male or female, age 18 or older ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to the DSM-5 criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI) iii. Meets diagnostic criteria for a substance use disorder within the last 3 months iv. Meets diagnostic criteria for a current anxiety disorder (generalized anxiety disorder, panic disorder, and/or social phobia) as confirmed by the Mini International Neuropsychiatric Interview (MINI) v. Currently in a depressive episode or currently in remission from a mood episode vi. Hamilton Anxiety Rating Scale total score ≥ 18 vii. Young Mania Rating Scale total score ≤ 8 viii. In the opinion of the investigator, capable of understanding and complying with protocol requirements ix. In the opinion of the investigator, has the competency to understand and sign the informed consent x. Subject is compliant with taking psychiatric medication(s) per the investigator's discretion b. Exclusion Criteria for Group 3: i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis) ii. Progressive neurological disease such as neurodegenerative disease iii. Any co-occurring lifetime or current obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), or attention deficit hyperactivity disorder (ADHD) iv. Meets criteria for antisocial personality disorder or borderline personality disorder as assessed by clinician assessment. v. Intoxicated or in acute withdrawal state. vi. Currently pregnant or planning to become pregnant. vii. Currently experiencing nicotine use disorder or any smoking of cigarettes or use of other nicotine containing products within a week before the eye tracking visit. viii. Has had ECT treatment within the last 6 months. 4. Inclusion and Exclusion Criteria for Group 4: Bipolar disorder without an anxiety disorder but with a current substance use disorder a. Inclusion Criteria for Group 4: i. Male or female, age 18 or older ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to the DSM-5 criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI) iii. Meets diagnostic criteria for a substance use disorder within the last 3 months iv. Currently in a depressive episode or currently in remission from a mood episode v. Young Mania Rating Scale total score ≤ 8 vi. Hamilton Anxiety Rating Scale total score ≤ 12 vii. In the opinion of the investigator, capable of understanding and complying with protocol requirements viii. In the opinion of the investigator, has the competency to understand and sign the informed consent ix. Subject is compliant with taking psychiatric medication(s) per the investigator's discretion b. Exclusion Criteria for Group 4: i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis) ii. Progressive neurological disease such as neurodegenerative disease iii. Any co-occurring current anxiety disorder or attention deficit hyperactivity disorder (ADHD) iv. Meets criteria for antisocial personality disorder or borderline personality disorder as assessed by clinician assessment. v. Intoxicated or in an acute withdrawal state vi. Currently pregnant or planning to become pregnant. vii. Currently experiencing nicotine use disorder or any smoking of cigarettes or use of other nicotine containing products within a week before the eye tracking visit. viii. Has had ECT treatment within the last 6 months. 5. Inclusion and exclusion criteria for Group 5: Healthy Volunteers 1. Inclusion criteria for Group 5: i. Male or female, age 18 or older ii. In the opinion of the investigator, capable of understanding and complying with protocol requirements iii. In the opinion of the investigator, has the competency to understand and sign the informed consent iv. Physically healthy as determined by research psychiatrist v. Without any current and/or lifetime psychiatric disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI) b. Exclusion Criteria for Group 5: i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis) ii. Progressive neurological disease such as neurodegenerative disease iii. Any psychiatric disorder including any severe personality disorder iv. Currently pregnant or planning to become pregnant v. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription vi. Currently taking any steroids, stimulants, or opioid pain killers. vii. Currently experiencing nicotine use disorder or any smoking of cigarettes or use of other nicotine containing products within a week before the eye tracking visit.