Partnership Program In Precision Psychiatry Biobank (P3 Biobank)

Overview

About this study

The purpose of this study is to create a a large database and bio-repository of clinical information and blood samples from participants with BD type- I (BD-I), type- II (BD-II) and schizoaffective disorder, bipolar type (SCZ-BD) and extending an invitation for some of our previous patients who participated in the Mayo Clinic Bipolar Biobank from 2009 to 2018 and MoStGEN Biobank from 2021 to 2025 to have them return for a second new blood draw for this new protocol.

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 18-80 years.

  • Diagnosis of BD-I or BD-II, or SCZ-BD by DSM-IV (SCID confirmed). If a participant has already completed a structured diagnostic interview within the 3 years, the existing SCID results can be used for the P3 biobank; thus, they will not be required to repeat the SCID assessment. If a structured diagnostic interview was completed more than 3 years ago, the current mood state sections of the SCID must be repeated to ensure accuracy of current mood state assessment.

  • Ability for a referring clinician or research clinician to complete a retrospective clinical assessment of response to lithium, mood stabilizing anticonvulsants (carbamazepine, oxcarbazepine, divalproex sodium, lamotrigine, zonisamide), typical and atypical antipsychotics, stimulants and related compounds (modafinil / armodafinil), and unimodal antidepressants utilizing the Alda scale.

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. impaired judgment, false fixed beliefs which are delusions or hallucinations) or active suicidal behavior (including active suicidal ideation or planning).

  • A score > 4 on question #10 of the MADRS, OR a score >2 on question #12 of QIDS-C16

  • A score of 20 or higher on the YMRS, OR a score of 6 or higher on question #8 of the YMRS

  • Immunocompromised patients who have received a blood transfusion within the past 6 weeks.

  • Involuntary patients.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

 

Eligibility last updated 05/08/2025. Questions regarding updates should be directed to the study team contact.

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 Contact

Mankato, Minn.

Mayo Clinic principal investigator

Satyajit Mohite

Open for enrollment

Contact information:

Laura Harper

(507) 255-9352

Harper.Laura1@mayo.edu

Austin, Minn.

Mayo Clinic principal investigator

Joshua Baruth

Open for enrollment

Contact information:

Laura Harper

(507) 255-9352

Harper.Laura1@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Mark Frye

Open for enrollment

Contact information:

Laura Harper

(507) 255-9352

Harper.Laura1@mayo.edu

More information

Publications

Publications are currently not available