A Study to Evaluate Positive SARS-CoV-2 Antibodies in Subjects with Bipolar Disorder
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-010109
About this study
The purpose of this study is to evaluate the clinical and neurocognitive correlates of COVID-19 in patients with bipolar disorder (BD).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age, 18-65 years.
- Diagnosis of BD-I or BD-II, or SCZ-BD by DSM-IV (SCID confirmed). Participants of the Bipolar Biobank (IRB # 08-008794) are patients with existing SCID results and participants enrolling to the MoStGEN protocol (IRB # 20-001658) are required to complete a SCID; thus they will not be required to repeat the SCID assessment. Only patients without a previous SCID will be interviewed to complete it.
- Subjects willing to provide consent to be blood-tested for SARS-CoV-2 IgG/IgM on each of the three visits.
Exclusion Criteria:
- Inability to understand English.
- Inability or unwillingness to provide informed consent or scoring less than 80% on the comprehension assessment (CA) form.
- Unwilling to consent to providing bio-specimens to be stored in the biobank for an indefinite amount of time and to be used in future research studies of as yet unknown design.
- Actively psychotic (i.e., paranoia, perceptual disturbances, delusional ideas, impaired judgment) or active suicidal behavior (including suicidal ideation or planning).
- Involuntary patients.
- Women with known pregnancy. (Due to the lack of conclusive data regarding the quality of antibody response during pregnancy, we considered it appropriate the exclusion of women with known pregnancy from this study).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mark Frye, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available