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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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 [Срок оценки: Baseline]
• Measure the differences in reward sensitivity among the 5 groups by assessing the amplitude of the saccade to reward and non-reward stimuli [Срок оценки: Baseline]
• Measure the differences in reward sensitivity among the 5 groups by assessing the velocity of the saccade to reward and non-reward stimuli [Срок оценки: Baseline]
• Measure the differences in cognitive control among the 5 groups by assessing the amplitude of the antisaccade [Срок оценки: Baseline]
• Measure the differences in cognitive control among the 5 groups by assessing the velocity of the antisaccade [Срок оценки: Baseline]

Критерии участия

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

• 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.

• 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.

• 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.

• 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.

• Inclusion and exclusion criteria for Group 5: Healthy Volunteers

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• University Hospitals Cleveland Medical Center - Mood Disorders Program — Cleveland

Идентификаторы

NCT: NCT03829787 · 09-17-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗