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

Bipolar Disorder Clinical Trial

Official title:

Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder and Different Psychiatric Comorbidities: An Eye-Tracking Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03829787
• Other study ID #: 09-17-03
• Status: Recruiting
• Start date: March 27, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: Nicole Jones
• Phone: 216/844-2862
• Email: mdp[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Device:
• Eye tracking
Subjects will be assessed for attentional biases, reward sensitivity, and cognitive control using eye tracking technology

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center - Mood Disorders Program	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline