Clinical trial NCT03829787: Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults with Bipolar Disorder
Official title: Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults with Bipolar Disorder and Different Psychiatric Comorbidities: an Eye-Tracking Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bipolar Disorder
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential subjects will those living in the greater Cleveland, OH area who respond to IRB approved advertising.

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.


Eligibility criteria: 1. Inclusion and Exclusion Criteria for Group 1: bipolar disorder without current anxiety or substance use disorder

   1. Inclusion Criteria for Group 1:

   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

   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.

Primary outcomes:
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
timeFrame: Baseline
measure: Measure the differences in reward sensitivity among the 5 groups by assessing the amplitude of the saccade to reward and non-reward stimuli
timeFrame: Baseline
measure: Measure the differences in reward sensitivity among the 5 groups by assessing the velocity of the saccade to reward and non-reward stimuli
timeFrame: Baseline
measure: Measure the differences in cognitive control among the 5 groups by assessing the amplitude of the antisaccade
timeFrame: Baseline
measure: Measure the differences in cognitive control among the 5 groups by assessing the velocity of the antisaccade
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center - Mood Disorders Program
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Keming Gao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: