Bipolar DisorderNCT03829787
Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder
An observational study of Bipolar Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Eye tracking
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2019to 1 Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential subjects will those living in the greater Cleveland, OH area who respond to IRB approved advertising.
- 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 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
- 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
- Exclusion Criteria for Group 1:
- 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
- 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.
- 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 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)
- 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
- Exclusion Criteria for Group 2:
- 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.
- 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.
- 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 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)
- 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
- 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) 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.
- 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.
- 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 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
- 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
- Exclusion Criteria for Group 4:
- 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.
- 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.
- Inclusion and exclusion criteria for Group 5: Healthy Volunteers
- Inclusion criteria for Group 5:
- 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
- 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) 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center - Mood Disorders Program
Cleveland, Ohio, 44106
Nicole Jones, MA, 216-844-2862, mdp@UHhospitals.org
Keming Gao, MD, PhD
About this study
Official title: 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.
- Conditions
- Bipolar Disorder
- Being tested
- Eye tracking
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye trackingDevice
Subjects will be assessed for attentional biases, reward sensitivity, and cognitive control using eye tracking technology
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Device: Eye tracking | |
| Healthy Volunteers | Not described Receives: Device: Eye tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start27 Mar 2019
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keming Gao, University Hospitals Cleveland Medical Center
- Investigators
- Keming Gao, MD, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829787
- Sponsor's protocol ID
- 09-17-03
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2018
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No