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

NCT ID: NCT03829787

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2026-09-01

Brief 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.

Conditions

Bipolar Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Bipolar without Anxiety or Substance Use Disorder

Subjects who are diagnosed with bipolar disorder but do not have any current anxiety or substance use disorders

Eye tracking

Intervention Type: DEVICE

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

Bipolar disorder with a current anxiety disorder only

Subjects who are diagnosed with bipolar disorder and a current anxiety disorder (generalized anxiety disorder, panic disorder, and/or social phobia) but not a current substance use disorders

Eye tracking

Intervention Type: DEVICE

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

Bipolar disorder with a current anxiety disorder and a current

Subjects who are diagnosed with bipolar disorder and a current anxiety disorder (generalized anxiety disorder, panic disorder, and/or social phobia) AND a current substance use disorders

Eye tracking

Intervention Type: DEVICE

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

Bipolar disorder with a current substance use disorder only

Subjects who are diagnosed with bipolar disorder \& a substance use disorders but not a current anxiety disorder

Eye tracking

Intervention Type: DEVICE

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

Healthy Volunteers

Eye tracking

Intervention Type: DEVICE

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

Interventions

Eye tracking

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Keming Gao

Director, Mood and Anxiety Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keming Gao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center - Mood Disorders Program

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicole Jones

Role: CONTACT

mdp@uhhospitals.org

216/844-2862

Facility Contacts

Nicole Jones, MA

Role: primary

mdp@UHhospitals.org

216-844-2862

Other Identifiers

09-17-03

Identifier Type: -

Identifier Source: org_study_id