RecruitingNCT03829787

Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder

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

Sponsor

University Hospitals Cleveland Medical Center

Enrollment

100 participants

Start Date

Mar 27, 2019

Study Type

OBSERVATIONAL

Conditions

Bipolar Disorder

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria40

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
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
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
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
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)

Exclusion Criteria41

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.
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.
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.
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.
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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEEye tracking

Subjects will be assessed for attentional biases, reward sensitivity, and cognitive control using eye tracking technology

Locations(1)

University Hospitals Cleveland Medical Center - Mood Disorders Program

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03829787

Related Trials

NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder

NCT056697031 location

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913103 locations

A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

NCT0728617588 locations

Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders

NCT074797581 location

Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study

NCT068976701 location