Clinical Trials

Inclusion Criteria:

• Age 18-80 years

• Diagnosis of bipolar I or II disorder, or BP schizoaffective Disorder by DSM-IV (SCID- confirmed). If a participant has already completed a structured diagnostic interview within the last 2 years, the existing SCID results can be used for this study; thus, they will not be required to repeat the SCID assessment. Suppose a structured diagnostic interview was completed more than 2 years ago. In that case, the current mood state sections of the SCID must be repeated to ensure accuracy of the current mood state assessment.

• Currently enrolled in a bipolar depression treatment protocol, or longitudinal follow up is already established at Mayo Clinic or planning to participate in an interventional clinical trial at Mayo Clinic for bipolar depression, including but not limited to: [(Ketogenic Intervention in Bipolar Depression – IRB: 24-013228), (Participants with bipolar depression enrolled in “Obesity Phenotyping in Bipolar Disorder” – IRB: 25-005856), (Participants with bipolar depression enrolled in “BD2 Integrated Network | Longitudinal Cohort Study ” – IRB: 23-004500) .

• Urine drug screen is negative except for allowable drugs that they have been prescribed, such as benzodiazepines, if we have that test in the previous 2 weeks we will not repeat it

• Pregnancy test is negative, a second pregnancy test is done before the 2^nd scan

Exclusion Criteria:

• Inability to provide written, voluntary, informed consent and scoring less than 80% on the comprehension assessment related to study goals, risks, and benefits.

• Structured clinical interview confirmation of schizophrenia or presence of psychotic symptoms (both SCID and YMRS question 8>5).

• Clinical diagnosis of personality disorder that, upon review by the study psychiatrist, of all available information (SCID, electronic health record), is the primary psychiatric diagnosis.

• Active suicidal ideation as defined by MADRS score >4 on question #10.

• Any current drug and alcohol use disorder (excluding nicotine); complete (not partial) remission ≥3 months.

• Positive toxicology screen for cannabis and cannabis use disorder by structured clinical interview. Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included if the Cannabis Use Disorder Identification Test (CUDIT-R) score is < 12.

• Presence of metal implants such as pacemakers, cochlear implants, or aneurysm clips.

• Pregnancy, or nursing

• History of claustrophobia

• Any contraindication on the MRI safety questionnaire

• Current involuntary psychiatric hospitalization.

• Any active or unstable medical condition judged by the principal investigator as conferring significant medical risk to allow inclusion in the study, such as active severe infection

• History or current diagnosis of liver failure or liver cirrhosis with significant impairment, defined as ALT or AST > 2.5 times the upper limit of normal.

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

Eligibility last updated 06/30/2025. Questions regarding updates should be directed to the study team contact.