<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03829787</url>
  </required_header>
  <id_info>
    <org_study_id>09-17-03</org_study_id>
    <nct_id>NCT03829787</nct_id>
  </id_info>
  <brief_title>Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder</brief_title>
  <official_title>Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder and Different Psychiatric Comorbidities: An Eye-Tracking Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to use eye-tracking technology to study attentional biases,&#xD;
      reward sensitivity, and cognitive control in adult patients with bipolar disorder with or&#xD;
      without anxiety and/or substance use disorder comorbidity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 27, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the differences in reward sensitivity among the 5 groups by assessing the amplitude of the saccade to reward and non-reward stimuli</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the differences in reward sensitivity among the 5 groups by assessing the velocity of the saccade to reward and non-reward stimuli</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the differences in cognitive control among the 5 groups by assessing the amplitude of the antisaccade</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the differences in cognitive control among the 5 groups by assessing the velocity of the antisaccade</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Bipolar without Anxiety or Substance Use Disorder</arm_group_label>
    <description>Subjects who are diagnosed with bipolar disorder but do not have any current anxiety or substance use disorders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bipolar disorder with a current anxiety disorder only</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bipolar disorder with a current anxiety disorder and a current</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bipolar disorder with a current substance use disorder only</arm_group_label>
    <description>Subjects who are diagnosed with bipolar disorder &amp; a substance use disorders but not a current anxiety disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Eye tracking</intervention_name>
    <description>Subjects will be assessed for attentional biases, reward sensitivity, and cognitive control using eye tracking technology</description>
    <arm_group_label>Bipolar disorder with a current anxiety disorder and a current</arm_group_label>
    <arm_group_label>Bipolar disorder with a current anxiety disorder only</arm_group_label>
    <arm_group_label>Bipolar disorder with a current substance use disorder only</arm_group_label>
    <arm_group_label>Bipolar without Anxiety or Substance Use Disorder</arm_group_label>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Potential subjects will those living in the greater Cleveland, OH area who respond to IRB&#xD;
        approved advertising.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Inclusion and Exclusion Criteria for Group 1: bipolar disorder without current anxiety&#xD;
             or substance use disorder&#xD;
&#xD;
               1. Inclusion Criteria for Group 1:&#xD;
&#xD;
             i. Male or female, age 18 or older&#xD;
&#xD;
             ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to&#xD;
             Diagnostic and Statistical Manual-5 (DSM-5) criteria, as confirmed by the Mini&#xD;
             International Neuropsychiatric Interview (MINI)&#xD;
&#xD;
             iii. Currently in a depressive episode or currently in remission from a mood episode&#xD;
&#xD;
             iv. Young Mania Rating Scale total score ≤ 8&#xD;
&#xD;
             v. In the opinion of the investigator, capable of understanding and complying with&#xD;
             protocol requirements&#xD;
&#xD;
             vi. In the opinion of the investigator, has the competency to understand and sign the&#xD;
             informed consent&#xD;
&#xD;
             vii. Subject is compliant with taking psychiatric medication(s) per the investigator's&#xD;
             discretion&#xD;
&#xD;
             b. Exclusion Criteria for Group 1:&#xD;
&#xD;
             i. Significant structural brain lesion (e.g. infarct, hemorrhage, tumor, multiple&#xD;
             sclerosis)&#xD;
&#xD;
             ii. Progressive neurological disease such as neurodegenerative disease&#xD;
&#xD;
             iii. Any current psychiatric disorder (other than a current depressive episode)&#xD;
             including anxiety disorders, substance use disorders, antisocial personality disorder&#xD;
             and borderline personality disorder as assessed by the MINI and clinician assessment.&#xD;
&#xD;
             iv. Currently pregnant or planning to become pregnant&#xD;
&#xD;
             v. Tests positive for illegal substances or prescription medications for which they do&#xD;
             not have a valid prescription&#xD;
&#xD;
             vi. Currently taking any steroids, stimulants, or opioid pain killers.&#xD;
&#xD;
             vii. Meets DSM-5 criteria for any alcohol and/or drug use disorder within the last 6&#xD;
             months, excluding the use of caffeine.Currently experiencing nicotine use disorder or&#xD;
             any smoking of cigarettes or use of other nicotine containing products within a week&#xD;
             before the eye tracking visit.&#xD;
&#xD;
             viii. Has had electroconvulsive therapy (ECT) treatment within the last 6 months.&#xD;
&#xD;
          2. Inclusion and Exclusion Criteria for Group 2: Bipolar disorder with a current anxiety&#xD;
             disorder (generalized anxiety disorder, panic disorder, and/or social phobia)&#xD;
&#xD;
             a. Inclusion Criteria for Group 2:&#xD;
&#xD;
             i. Male or female, age 18 or older&#xD;
&#xD;
             ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to DSM-5&#xD;
             criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI)&#xD;
&#xD;
             iii. Currently in a depressive episode or currently in remission from a mood episode&#xD;
&#xD;
             iv. Meets diagnostic criteria for a current anxiety disorder (generalized anxiety&#xD;
             disorder, panic disorder, and/or social phobia) as confirmed by the Mini International&#xD;
             Neuropsychiatric Interview (MINI)&#xD;
&#xD;
             v. Hamilton Anxiety Rating Scale total score ≥ 18&#xD;
&#xD;
             vi. Young Mania Rating Scale total score ≤ 8&#xD;
&#xD;
             vii. In the opinion of the investigator, capable of understanding and complying with&#xD;
             protocol requirements&#xD;
&#xD;
             viii. In the opinion of the investigator, has the competency to understand and sign&#xD;
             the informed consent&#xD;
&#xD;
             ix. Subject is compliant with taking psychiatric medication(s) per the investigator's&#xD;
             discretion&#xD;
&#xD;
             b. Exclusion Criteria for Group 2:&#xD;
&#xD;
             i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor,&#xD;
             multiple sclerosis)&#xD;
&#xD;
             ii. Progressive neurological disease such as neurodegenerative disease&#xD;
&#xD;
             iii. Any co-occurring lifetime or current obsessive-compulsive disorder (OCD),&#xD;
             post-traumatic stress disorder (PTSD), or attention deficit hyperactivity disorder&#xD;
             (ADHD)&#xD;
&#xD;
             iv. Meets criteria for antisocial personality disorder or borderline personality&#xD;
             disorder as assessed by clinician assessment.&#xD;
&#xD;
             v. Currently pregnant or planning to become pregnant&#xD;
&#xD;
             vi. Tests positive for illegal substances or prescription medications for which they&#xD;
             do not have a valid prescription&#xD;
&#xD;
             vii. Currently taking any steroids, stimulants, or opioid pain killers.&#xD;
&#xD;
             viii. Meets DSM-5 criteria for any alcohol and/or drug use disorder within the last 6&#xD;
             months, excluding the use of caffeine&#xD;
&#xD;
             ix. Currently experiencing nicotine use disorder or any smoking of cigarettes or use&#xD;
             of other nicotine containing products within a week before the eye tracking visit.&#xD;
&#xD;
             x. Has had ECT treatment within the last 6 months.&#xD;
&#xD;
          3. Inclusion and Exclusion Criteria for Group 3: Bipolar disorder with a current anxiety&#xD;
             disorder and a current substance use disorder&#xD;
&#xD;
             a. Inclusion Criteria for Group 3:&#xD;
&#xD;
             i. Male or female, age 18 or older&#xD;
&#xD;
             ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to the&#xD;
             DSM-5 criteria, as confirmed by the Mini International Neuropsychiatric Interview&#xD;
             (MINI)&#xD;
&#xD;
             iii. Meets diagnostic criteria for a substance use disorder within the last 3 months&#xD;
&#xD;
             iv. Meets diagnostic criteria for a current anxiety disorder (generalized anxiety&#xD;
             disorder, panic disorder, and/or social phobia) as confirmed by the Mini International&#xD;
             Neuropsychiatric Interview (MINI)&#xD;
&#xD;
             v. Currently in a depressive episode or currently in remission from a mood episode&#xD;
&#xD;
             vi. Hamilton Anxiety Rating Scale total score ≥ 18&#xD;
&#xD;
             vii. Young Mania Rating Scale total score ≤ 8&#xD;
&#xD;
             viii. In the opinion of the investigator, capable of understanding and complying with&#xD;
             protocol requirements&#xD;
&#xD;
             ix. In the opinion of the investigator, has the competency to understand and sign the&#xD;
             informed consent&#xD;
&#xD;
             x. Subject is compliant with taking psychiatric medication(s) per the investigator's&#xD;
             discretion&#xD;
&#xD;
             b. Exclusion Criteria for Group 3:&#xD;
&#xD;
             i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor,&#xD;
             multiple sclerosis)&#xD;
&#xD;
             ii. Progressive neurological disease such as neurodegenerative disease&#xD;
&#xD;
             iii. Any co-occurring lifetime or current obsessive-compulsive disorder (OCD),&#xD;
             post-traumatic stress disorder (PTSD), or attention deficit hyperactivity disorder&#xD;
             (ADHD)&#xD;
&#xD;
             iv. Meets criteria for antisocial personality disorder or borderline personality&#xD;
             disorder as assessed by clinician assessment.&#xD;
&#xD;
             v. Intoxicated or in acute withdrawal state.&#xD;
&#xD;
             vi. Currently pregnant or planning to become pregnant.&#xD;
&#xD;
             vii. Currently experiencing nicotine use disorder or any smoking of cigarettes or use&#xD;
             of other nicotine containing products within a week before the eye tracking visit.&#xD;
&#xD;
             viii. Has had ECT treatment within the last 6 months.&#xD;
&#xD;
          4. Inclusion and Exclusion Criteria for Group 4: Bipolar disorder without an anxiety&#xD;
             disorder but with a current substance use disorder&#xD;
&#xD;
             a. Inclusion Criteria for Group 4:&#xD;
&#xD;
             i. Male or female, age 18 or older&#xD;
&#xD;
             ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to the&#xD;
             DSM-5 criteria, as confirmed by the Mini International Neuropsychiatric Interview&#xD;
             (MINI)&#xD;
&#xD;
             iii. Meets diagnostic criteria for a substance use disorder within the last 3 months&#xD;
&#xD;
             iv. Currently in a depressive episode or currently in remission from a mood episode&#xD;
&#xD;
             v. Young Mania Rating Scale total score ≤ 8&#xD;
&#xD;
             vi. Hamilton Anxiety Rating Scale total score ≤ 12&#xD;
&#xD;
             vii. In the opinion of the investigator, capable of understanding and complying with&#xD;
             protocol requirements&#xD;
&#xD;
             viii. In the opinion of the investigator, has the competency to understand and sign&#xD;
             the informed consent&#xD;
&#xD;
             ix. Subject is compliant with taking psychiatric medication(s) per the investigator's&#xD;
             discretion&#xD;
&#xD;
             b. Exclusion Criteria for Group 4:&#xD;
&#xD;
             i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor,&#xD;
             multiple sclerosis)&#xD;
&#xD;
             ii. Progressive neurological disease such as neurodegenerative disease&#xD;
&#xD;
             iii. Any co-occurring current anxiety disorder or attention deficit hyperactivity&#xD;
             disorder (ADHD)&#xD;
&#xD;
             iv. Meets criteria for antisocial personality disorder or borderline personality&#xD;
             disorder as assessed by clinician assessment.&#xD;
&#xD;
             v. Intoxicated or in an acute withdrawal state&#xD;
&#xD;
             vi. Currently pregnant or planning to become pregnant.&#xD;
&#xD;
             vii. Currently experiencing nicotine use disorder or any smoking of cigarettes or use&#xD;
             of other nicotine containing products within a week before the eye tracking visit.&#xD;
&#xD;
             viii. Has had ECT treatment within the last 6 months.&#xD;
&#xD;
          5. Inclusion and exclusion criteria for Group 5: Healthy Volunteers&#xD;
&#xD;
               1. Inclusion criteria for Group 5:&#xD;
&#xD;
             i. Male or female, age 18 or older&#xD;
&#xD;
             ii. In the opinion of the investigator, capable of understanding and complying with&#xD;
             protocol requirements&#xD;
&#xD;
             iii. In the opinion of the investigator, has the competency to understand and sign the&#xD;
             informed consent&#xD;
&#xD;
             iv. Physically healthy as determined by research psychiatrist&#xD;
&#xD;
             v. Without any current and/or lifetime psychiatric disorder as confirmed by the Mini&#xD;
             International Neuropsychiatric Interview (MINI)&#xD;
&#xD;
             b. Exclusion Criteria for Group 5:&#xD;
&#xD;
             i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor,&#xD;
             multiple sclerosis)&#xD;
&#xD;
             ii. Progressive neurological disease such as neurodegenerative disease&#xD;
&#xD;
             iii. Any psychiatric disorder including any severe personality disorder&#xD;
&#xD;
             iv. Currently pregnant or planning to become pregnant&#xD;
&#xD;
             v. Tests positive for illegal substances or prescription medications for which they do&#xD;
             not have a valid prescription&#xD;
&#xD;
             vi. Currently taking any steroids, stimulants, or opioid pain killers.&#xD;
&#xD;
             vii. Currently experiencing nicotine use disorder or any smoking of cigarettes or use&#xD;
             of other nicotine containing products within a week before the eye tracking visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keming Gao, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicole Jones</last_name>
    <phone>216/844-2862</phone>
    <email>mdp@uhhospitals.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center - Mood Disorders Program</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Jones, MA</last_name>
      <phone>216-844-2862</phone>
      <email>mdp@UHhospitals.org</email>
    </contact>
    <investigator>
      <last_name>Keming Gao, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 10, 2018</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Keming Gao</investigator_full_name>
    <investigator_title>Director, Mood and Anxiety Clinic</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03829787
org study id: 09-17-03
nct id: NCT03829787
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: 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
time frame: Baseline
description: 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.
measure: Measure the differences in reward sensitivity among the 5 groups by assessing the amplitude of the saccade to reward and non-reward stimuli
time frame: Baseline
description: 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.
measure: Measure the differences in reward sensitivity among the 5 groups by assessing the velocity of the saccade to reward and non-reward stimuli
time frame: Baseline
description: 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.
measure: Measure the differences in cognitive control among the 5 groups by assessing the amplitude of the antisaccade
time frame: Baseline
description: 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.
measure: Measure the differences in cognitive control among the 5 groups by assessing the velocity of the antisaccade
time frame: Baseline
description: 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.
arm group label: Bipolar without Anxiety or Substance Use Disorder
description: Subjects who are diagnosed with bipolar disorder but do not have any current anxiety or substance use disorders
arm group label: Bipolar disorder with a current anxiety disorder only
description: 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
arm group label: Bipolar disorder with a current anxiety disorder and a current
description: 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
arm group label: Bipolar disorder with a current substance use disorder only
description: Subjects who are diagnosed with bipolar disorder & a substance use disorders but not a current anxiety disorder
arm group label: Healthy Volunteers
intervention type: Device
intervention name: Eye tracking
description: Subjects will be assessed for attentional biases, reward sensitivity, and cognitive control using eye tracking technology
arm group label: Bipolar disorder with a current anxiety disorder and a current
arm group label: Bipolar disorder with a current anxiety disorder only
arm group label: Bipolar disorder with a current substance use disorder only
arm group label: Bipolar without Anxiety or Substance Use Disorder
arm group label: Healthy Volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Keming Gao, MD, PhD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
last name: Nicole Jones
phone: 216/844-2862
email: mdp@uhhospitals.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Keming Gao
investigator title: Director, Mood and Anxiety Clinic
mesh term: Bipolar Disorder
sharing ipd: No