Schizophrenia Spectrum Biomarkers Consortium (SSBC)

Interested in Participating in a Study about Brain Function?

Yale University is recruiting healthy volunteers and individuals with a schizophrenia or bipolar spectrum diagnosis ages of 18-50 for a study on brain function. Study includes lumbar puncture, brain imaging (MRI), blood draw and computer games.

Compensation up to $650.

Contact Lia Urban Spillane at lia.urbanspillane@yale.edu or 203-626-1105

Learn more here: https://ssbcbio.org/study_sites.html

Inclusion criteria

Schizophrenia spectrum disorder (SSD)

• Ages 18 to 50 (from first episode to up to 10 years after initial diagnosis of schizophrenia in a clinical setting)

• DSM criteria for schizophrenia, schizoaffective disorder, or schizophreniform

Bipolar disorder I (BD I)

• Ages 18 to 50 (from first episode to up to 10 years after initial diagnosis of bipolar disorder I in a clinical setting)

• DSM criteria for bipolar disorder I with or without psychosis

Healthy individuals

• Ages 18 to 50 (chosen to be similar in demographics to individuals with SSD and BD I).

• No lifetime major psychiatric (or DSM) diagnoses such as schizophrenia/ bipolar disorder based on the clinical assessment. Some lifetime diagnoses may be permitted (e.g., remote history of depressive episode, adjustment disorder, ADD) also based on clinical assessment and PI discretion.

Inclusion criteria for all participants

• Consent to participate

• Able to undergo an MRI

Exclusion criteria for all participants (safety, comorbidity and MRI/LP-related):

• Imminent risk of harm to self or others (e.g., Active suicidal ideation with intent or plan, per Columbia Suicide Severity Rating Scale; CSSR-S).

• Siblings and family members of patient participants may be excluded as healthy controls for this study.

• History of clinically significant autoimmune disease (such as Lupus, rheumatoid arthritis, Crohn’s disease, ulcerative colitis) and any unstable clinically significant medical condition. (Participants will be encouraged to discuss with the primary investigator or the medical monitor if they have a diagnosis that may qualify as listed above.)

• Drugs/Medication:

• ○ Significant problems with substance use over the past 6 months meeting criteria for dependence (DSM IV) or moderate to severe substance use disorder (DSM V) per clinical assessments (apart from tobacco use).

• Note: All participants will be asked to refrain from substance use (e.g., recreational drugs, alcohol, etc) before the sample collection and assessments (e.g., for about 1 month before the SCID).

• ○ Immunomodulatory therapy (daily, weekly or monthly) within the last 3 months, such as treatment with mycophenolate mofetil (Cellcept), methotrexate, cyclophosphamide (Cytoxan), azathriopine (Imuran), natulizumab (Tysabri), intravenous Immunoglobulin (IVIg).

• ○ Longer acting immunomodulatory therapy in the last 12 months, such as treatment with rituximab (Rituxan), alemtuzumab (Lemtrada).

• Any abnormality or deformity in the spine that precludes lumbar puncture.

• History of subarachnoid hemorrhage, suspicion of normal pressure hydrocephalus, prior neurosurgical procedures, CNS neoplasm, or prior emergency visit for headache within 1 month of prior lumbar puncture.

• Not willing to provide informed consent

• Not able to undergo MRI (as needed before LP)

• ○ Any metal or paramagnetic material in the body except tooth fillings or minor dental work considered safe for MRI (e.g., presence of biomedical devices, implants or metallic objects such as pacemaker, metallic clip, neurostimulator, stents, breast tissue expander, piercings, RFID, hearing aid; transdermal patch), including metallic bodies embedded or likely to be embedded in soft tissue in the eye or elsewhere (e.g., from metal work).

• ○ Positive pregnancy screen.

• BMI >40 (Body habitus too large for magnet bore) and/or clinically significant claustrophobia and/or known inability to tolerate MRI scan.