Clinical Trials

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.