This research study examines how a medication called lumateperone may affect mood symptoms, and inflammation in adults with bipolar disorder over approximately 6 weeks. An MRI scan to calculate biological age of the brain will also be obtained at the start of the study.
Aged 18 to 65 years.
Meets DSM-V criteria for Bipolar I Disorder -Depressed without psychosis as confirmed by a semi-structured clinical interview that includes the Mini International Neuropsychiatric Interview.
Current episode at least 4 weeks in duration but not longer than 12 months.
Depression score > 20 on the Montgomery Asberg Depression Rating Scale (MADRS).
Meets DSM-V criteria for Schizophrenia, Schizoaffective disorder, or has significant mood-incongruent psychotic symptoms.
Young Mania Rating Scale score >12.
Meets DSM-V criteria for rapid cycling.
Co-Morbid psychiatric illness, other than generalized anxiety and specific phobias, that in the opinion of the investigator is severe enough that it would likely interfere with the interpretation of changes in the subject's mood state.
Single group
Lumateperone 42 mg
DrugLumateperone 42 mg orally daily
MADRS
Montgomery Asperg Depression Rating Scale
Inflammatory Markers
Tissue Necrosis factor alpha, C-reactive protein, Interleukins 1 beta, 6, 18
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Massachusetts General Hospital
Lead sponsor
Johnson & Johnson K.K. Medical Company
Collaborator
