Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder
Recruiting
Observational Study
Bipolar Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
University Hospitals Cleveland Medical Center · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
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Status
Eligibility 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 Statis…
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.
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