Study to Distinguish Mood Disorders


About this study

The goal of this proposed study is to examine the genetic signature of the validated proteomic signature (model) based on a panel of serum proteomic markers that discriminates different mood disorders.

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:

  • Diagnosed with BPI, BPII, or MDD, confirmed with the Structured Clinical Interview for DSM-IV (SCID) and a consensus meeting of the study team.
  • Currently depressed for ≥8 weeks and ≤104 weeks, without psychotic features,
  • MADRS score ≥ 20 (consistent with at least moderate-severe depression)
  • YMRS score ≤ 8 (consistent with the absence of hypomanic symptoms)
  • Aged 18-70
  • Capacity to understand the nature of the study and give informed consent
  • BP patients must be enrolled in the Bipolar Biobank before or within 1 week of enrolling to this study and obtaining blood samples for proteomic study.
  • MDD patients must consent to get their blood samples for proteomic and genomic analyses..

Exclusion Criteria:

  • At high risk for suicide, defined as a score ≥4 on item 10 of the MADRS
  • Current depression has psychotic features, diagnosed with the SCID
  • Partially-treated current depression, defined as a change in treatment for depression (new treatment or change in dose of pre-existing treatment) in the past 4 weeks
  • Treated with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or clozapine in the past 6 months
  • Meeting criteria for substance use disorders, as defined by DSM-IV, in the past 3 months, except for caffeine or nicotine. (Limited substance use, not meeting criteria for substance use disorders, is not exclusionary). A positive drug screen will also be exclusionary.
  • Medical conditions with neurological sequelae (eg. stroke, brain cancer, multiple sclerosis, loss of consciousness > 30 min, HIV)
  • Severe chronic pain requiring treatment with opiate analgesics
  • Receiving treatment with high-potency immune-modulating medications, such as corticosteroids, chemotherapy, monoclonal antibodies, or disease-modifying agents for arthritis, multiple sclerosis
  • Any acute unstable medical illness (at the discretion of the investigator)
  • In MDD patients: strong risk factors for bipolarity, including 1) short (1-3 day) mood elevations not meeting DSM-IV time criteria for hypomania; 2) a family history of BDI or BDII in a first-degree relative; and 3) a history of antidepressant-induced symptoms suggestive of bipolarity, particularly antidepressant-induced hypo/mania.
  • In females: pregnancy (as determined by a positive urine pregnancy test within 7 days of the baseline blood sample collection).


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


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