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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

  1. Inclusion and Exclusion Criteria for Group 1: bipolar disorder without current anxiety

    or substance use disorder

    1. Inclusion Criteria for Group 1:
    2. 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
             b. Exclusion Criteria for Group 1:
             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.
          2. Inclusion and Exclusion Criteria for Group 2: Bipolar disorder with a current anxiety
             disorder (generalized anxiety disorder, panic disorder, and/or social phobia)
             a. Inclusion Criteria for Group 2:
             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
             b. Exclusion Criteria for Group 2:
             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.
          3. Inclusion and Exclusion Criteria for Group 3: Bipolar disorder with a current anxiety
             disorder and a current substance use disorder
             a. Inclusion Criteria for Group 3:
             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
             b. Exclusion Criteria for Group 3:
             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.
          4. Inclusion and Exclusion Criteria for Group 4: Bipolar disorder without an anxiety
             disorder but with a current substance use disorder
             a. Inclusion Criteria for Group 4:
             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
             b. Exclusion Criteria for Group 4:
             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.
          5. Inclusion and exclusion criteria for Group 5: Healthy Volunteers
               1. Inclusion criteria for Group 5:
             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)
             b. Exclusion Criteria for Group 5:
             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.

Study details

Bipolar Disorder

NCT03829787

University Hospitals Cleveland Medical Center

26 January 2024

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