๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โค 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 โฅ 18
vi. Young Mania Rating Scale total score โค 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 โฅ 18
vii. Young Mania Rating Scale total score โค 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