A Study of State-Specific Blood Marker Investigation in Bipolar and Schizoaffective Disorder
Overview
Tab Title Description
Study type
ObservationalDescribes 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: 13-006891
Sponsor Protocol Number: 13-006891
About this study
The purpose of this study is to find out if some patients with mood symptoms have antibodies (part of the immune system) that affect the brain, and could possibly play a role in the development of mood symptoms. We also want to find out if these immune markers change once your mood normalizes.
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 18-55, male or female, any race/ethnicity
- Diagnosis of
- Bipolar I disorder
- Bipolar I disorder
- Most recent episode hypomanic, manic, or mixed
- Bipolar II disorder
- Most recent episode hypomanic; or schizoaffective disorder, most recent episode hypomanic, manic, or mixed
- YMRS ≥12
Exclusion Criteria:
- Inability to speak English
- Inability or lack of willingness to provide informed consent, including current involuntary treatment or hospitalization
- Outpatients with active suicidality as defined by a score of 2 or higher on question # 18 of the Inventory for Depressive Symptoms (IDS)
- Active psychosis, defined by delusional thought content or hallucinations, as identified by clinical examination or on diagnostic interview.
- Active or unstable medical condition as evaluated by clinical interviewer
- Presence of co-morbid Axis I or Axis II disorder that is the primary diagnosis and current focus of treatment
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available