Eye Tracking Study of Attention and Reward in Adults With Bipolar Disorder

Trial details

Who runs it

University Hospitals Cleveland Medical Center

Trial code

NCT03829787

Record updated

9 October 2026

Original description

The purpose of this study is to use eye-tracking technology to study attentional biases, reward sensitivity, and cognitive control in adult patients with bipolar disorder with or without anxiety and/or substance use disorder comorbidity.Read full original descriptionShow less

Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder and Different Psychiatric Comorbidities: An Eye-Tracking Study

The purpose of this study is to use eye-tracking technology to study attentional biases, reward sensitivity, and cognitive control in adult patients with bipolar disorder with or without anxiety and/or substance use disorder comorbidity.

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

ClinicalTrials.gov NCT03829787