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



Status:Recruiting
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:March 27, 2019
End Date:September 1, 2020
Contact:Nicole Jones
Email:mdp@uhhospitals.org
Phone:216/844-2862

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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.


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.
We found this trial at
1
site
Cleveland, Ohio 44106
Principal Investigator: Keming Gao, MD, PhD
Phone: 216-844-2862
?
mi
from
Cleveland, OH
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