Status:
RECRUITING
Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
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/o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03829787
Start Date
March 27 2019
End Date
September 1 2026
Last Update
October 10 2025
Active Locations (1)
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1
University Hospitals Cleveland Medical Center - Mood Disorders Program
Cleveland, Ohio, United States, 44106