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

University Hospitals (UH)

Status: Enrolling

Conditions: Bipolar Disorder

Treatments: Device: Eye tracking

Study type: Observational

Funder types: Other

Identifiers

NCT03829787

09-17-03

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

100 participants in 5 patient groups

Bipolar without Anxiety or Substance Use Disorder

Description:

Subjects who are diagnosed with bipolar disorder but do not have any current anxiety or substance use disorders

Treatment:

Device: Eye tracking

Bipolar disorder with a current anxiety disorder only

Description:

Subjects who are diagnosed with bipolar disorder and a current anxiety disorder (generalized anxiety disorder, panic disorder, and/or social phobia) but not a current substance use disorders

Treatment:

Device: Eye tracking

Bipolar disorder with a current anxiety disorder and a current

Description:

Subjects who are diagnosed with bipolar disorder and a current anxiety disorder (generalized anxiety disorder, panic disorder, and/or social phobia) AND a current substance use disorders

Treatment:

Device: Eye tracking

Bipolar disorder with a current substance use disorder only

Description:

Subjects who are diagnosed with bipolar disorder \& a substance use disorders but not a current anxiety disorder

Treatment:

Device: Eye tracking

Healthy Volunteers

Treatment:

Device: Eye tracking