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

NCT03829787 | Recruiting DMC FDA Device

• 1 other identifier: 09-17-03
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Measure the differences in attentional bias among the 5 groups by assessing how long it takes a subject to locate and fixate on each face on the screen

  This paradigm involves the simultaneous presentation of 2 facial images. Two facial expressions (happy-neutral, sad-neutral, fearful-neutral, and neutral-neutral) from the same actor are presented simultaneously on each side of the screen. For each participant, happy, sad, fearful, and neutral facial expressions are randomly assigned to each side with each emotion category presented on each side with equal frequency. Each trial presents happy-neutral, sad-neutral, fearful-neutral and neutral-neutral facial expression in a new random order for each participant. Each trial begins with a central cross, followed by presentation of facial stimuli for 250-500 ms. Direction of gaze is measured with x and y coordinates. The latency and velocity of eye movement will be measured. Eye movements that are stable for more than 100 msec within 1˚of visual angle are classified as a fixation. The time to locate the face and fixation time to each face will be compared.

  Baseline

• Measure the differences in reward sensitivity among the 5 groups by assessing the amplitude of the saccade to reward and non-reward stimuli

  The reward paradigm is to measure amplitude and velocity of saccades toward reward stimuli. A saccade is a rapid eye movement made by the primate and human after they make their decision among several options. The participant will be told that he/she will be rewarded for a making a correct saccade in response to congruent conditional stimulus and she/he will not be rewarded for making a correct saccade in response to an incongruent stimulus. Each participant will have 5-10 trials to practice before the recording begins. The velocity and amplitude of saccade to reward and non-reward stimuli will be recorded for each trials. The mean velocity and amplitude to reward and non-reward stimuli among the different groups of patients will be compared.

  Baseline

• Measure the differences in reward sensitivity among the 5 groups by assessing the velocity of the saccade to reward and non-reward stimuli

  The reward paradigm is to measure amplitude and velocity of saccades toward reward stimuli. A saccade is a rapid eye movement made by the primate and human after they make their decision among several options. The participant will be told that he/she will be rewarded for a making a correct saccade in response to congruent conditional stimulus and she/he will not be rewarded for making a correct saccade in response to an incongruent stimulus. Each participant will have 5-10 trials to practice before the recording begins. The velocity and amplitude of saccade to reward and non-reward stimuli will be recorded for each trials. The mean velocity and amplitude to reward and non-reward stimuli among the different groups of patients will be compared.

  Baseline

• Measure the differences in cognitive control among the 5 groups by assessing the amplitude of the antisaccade

  Antisaccade (AS) performance is a sensitive marker for cognitive control of behavior and executive functioning. In contrast to saccade, antisaccade is an eye movement away from a target of reward or non-reward stimulus. Commonly used antisaccade paradigm includes cue, preparation, and response execution. In this protocol, the patients will learn to make an antisaccade to a reward or non-reward stimulus. Patients will receive a reward for each correct antisaccade movement to reward stimuli. The paradigm will include equal number of reward and non-reward trials. Trials are pseudorandomized across runs. For the reward condition, the value of any single correct response is intentionally ambiguous to prevent subjects from keeping a running total of earnings during the task.

  Baseline

• Measure the differences in cognitive control among the 5 groups by assessing the velocity of the antisaccade

  Antisaccade (AS) performance is a sensitive marker for cognitive control of behavior and executive functioning. In contrast to saccade, antisaccade is an eye movement away from a target of reward or non-reward stimulus. Commonly used antisaccade paradigm includes cue, preparation, and response execution. In this protocol, the patients will learn to make an antisaccade to a reward or non-reward stimulus. Patients will receive a reward for each correct antisaccade movement to reward stimuli. The paradigm will include equal number of reward and non-reward trials. Trials are pseudorandomized across runs. For the reward condition, the value of any single correct response is intentionally ambiguous to prevent subjects from keeping a running total of earnings during the task.

  Baseline

Study Arms (5)

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

Device: Eye tracking

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

Device: Eye tracking

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

Device: Eye tracking

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

Device: Eye tracking

Healthy Volunteers

Device: Eye tracking

Interventions

Eye tracking 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; Bipolar disorder with a current anxiety disorder only; Bipolar disorder with a current substance use disorder only; Bipolar without Anxiety or Substance Use Disorder; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects will those living in the greater Cleveland, OH area who respond to IRB approved advertising.

You may not qualify if:

• 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. 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center - Mood Disorders Program

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Keming Gao, MD, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Jones

CONTACT

216/844-2862; mdp@uhhospitals.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mood and Anxiety Clinic

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: February 4, 2019
• Study Start: March 27, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)