NCT03829787Toboroz
Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder
Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder and Different Psychiatric Comorbidities: An Eye-Tracking Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 9.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2018. júl. 10.
- Kezdés
- 2019. márc. 27.
- Elsődleges befejezés
- 2027. ápr. 1.
- Fő szponzor
- University Hospitals Cleveland Medical Center
- Betegségek
- Bipoláris zavar
- NCT-szám
- NCT03829787
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 100
- 2019. márc. 27. és az elsődleges befejezés (2027. ápr. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
A regiszterben nem jelölt feltételek
- Inclusion and Exclusion Criteria for Group 1: bipolar disorder without current anxiety or substance use disorder
- Inclusion Criteria for Group 1:
- Male or female, age 18 or older
- 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)
- Currently in a depressive episode or currently in remission from a mood episode
- Young Mania Rating Scale total score ≤ 8
- In the opinion of the investigator, capable of understanding and complying with protocol requirements
- In the opinion of the investigator, has the competency to understand and sign the informed consent
- Subject is compliant with taking psychiatric medication(s) per the investigator's discretion
- Exclusion Criteria for Group 1:
- Significant structural brain lesion (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
- Progressive neurological disease such as neurodegenerative disease
- 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.
- Currently pregnant or planning to become pregnant
- Tests positive for illegal substances or prescription medications for which they do not have a valid prescription
- Currently taking any steroids, stimulants, or opioid pain killers.
- 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.
- 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)
- Inclusion Criteria for Group 2:
- Male or female, age 18 or older
- Meets diagnostic criteria for lifetime bipolar I or II disorder according to DSM-5 criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Currently in a depressive episode or currently in remission from a mood episode
- 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)
- Hamilton Anxiety Rating Scale total score ≥ 18
- Young Mania Rating Scale total score ≤ 8
- In the opinion of the investigator, capable of understanding and complying with protocol requirements
- In the opinion of the investigator, has the competency to understand and sign the informed consent
- Subject is compliant with taking psychiatric medication(s) per the investigator's discretion
- Exclusion Criteria for Group 2:
- Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
- Progressive neurological disease such as neurodegenerative disease
- Any co-occurring lifetime or current obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), or attention deficit hyperactivity disorder (ADHD)
- Meets criteria for antisocial personality disorder or borderline personality disorder as assessed by clinician assessment.
- Currently pregnant or planning to become pregnant
- Tests positive for illegal substances or prescription medications for which they do not have a valid prescription
- Currently taking any steroids, stimulants, or opioid pain killers.
- 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.
- 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
- Inclusion Criteria for Group 3:
- Male or female, age 18 or older
- 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)
- Meets diagnostic criteria for a substance use disorder within the last 3 months
- 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)
- Currently in a depressive episode or currently in remission from a mood episode
- Hamilton Anxiety Rating Scale total score ≥ 18
- Young Mania Rating Scale total score ≤ 8
- In the opinion of the investigator, capable of understanding and complying with protocol requirements
- In the opinion of the investigator, has the competency to understand and sign the informed consent
- Subject is compliant with taking psychiatric medication(s) per the investigator's discretion
- Exclusion Criteria for Group 3:
- Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
- Progressive neurological disease such as neurodegenerative disease
- Any co-occurring lifetime or current obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), or attention deficit hyperactivity disorder (ADHD)
- Meets criteria for antisocial personality disorder or borderline personality disorder as assessed by clinician assessment.
- Intoxicated or in acute withdrawal state.
- Currently pregnant or planning to become pregnant.
- 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.
- 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
- Inclusion Criteria for Group 4:
- Male or female, age 18 or older
- 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)
- Meets diagnostic criteria for a substance use disorder within the last 3 months
- Currently in a depressive episode or currently in remission from a mood episode
- Young Mania Rating Scale total score ≤ 8
- Hamilton Anxiety Rating Scale total score ≤ 12
- In the opinion of the investigator, capable of understanding and complying with protocol requirements
- In the opinion of the investigator, has the competency to understand and sign the informed consent
- Subject is compliant with taking psychiatric medication(s) per the investigator's discretion
- Exclusion Criteria for Group 4:
- Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
- Progressive neurological disease such as neurodegenerative disease
- Any co-occurring current anxiety disorder or attention deficit hyperactivity disorder (ADHD)
- Meets criteria for antisocial personality disorder or borderline personality disorder as assessed by clinician assessment.
- Intoxicated or in an acute withdrawal state
- Currently pregnant or planning to become pregnant.
- 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.
- Has had ECT treatment within the last 6 months.
- Inclusion and exclusion criteria for Group 5: Healthy Volunteers
- Inclusion criteria for Group 5:
- Male or female, age 18 or older
- In the opinion of the investigator, capable of understanding and complying with protocol requirements
- In the opinion of the investigator, has the competency to understand and sign the informed consent
- Physically healthy as determined by research psychiatrist
- Without any current and/or lifetime psychiatric disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Exclusion Criteria for Group 5:
- Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
- Progressive neurological disease such as neurodegenerative disease
- Any psychiatric disorder including any severe personality disorder
- Currently pregnant or planning to become pregnant
- Tests positive for illegal substances or prescription medications for which they do not have a valid prescription
- Currently taking any steroids, stimulants, or opioid pain killers.
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Hospitals Cleveland Medical Center - Mood Disorders Program | Cleveland | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.