The purpose of this research study is to examine how well a medication called lumateperone (Caplyta) works to relieve depression in older adults with treatment-resistant depression. Lumateperone (Caplyta) is approved by the U.S. Food and Drug Administration to treat Major Depressive Disorder in adults who are also taking another antidepressant medication. This study will compare lumateperone (Caplyta) to placebo (a sugar pill without medication).
Age >=60
Current unipolar non-psychotic major depression determined by SCID-5
MADRS score >=20 at screening and >=18 at baseline
Treatment-resistance defined as documented history of non-response to at least two oral medications of adequate dose and duration in this episode or previous episode, OR clinician determination that treatment augmentation is appropriate
Dementia
High risk for suicide, defined as a 4 or 5 on C-SSRS (indicating active suicidal ideation with current or recent intent or plan), and unable to be managed safely in the clinical trial. Urgent psychiatric referral will be made in these cases.
High risk alcohol use: defined as a score of 6 or more on the AUDIT-C
Medically inappropriate for participation as determined by PIs.
Parallel
Lumateperone
DrugParticipants will be randomized to take either lumateperone or placebo along with their existing antidepressant for 10 weeks. Dose will range from 10.5mg-42mg over the course of the study.
Placebo
DrugParticipants will be randomized to take either lumateperone or placebo along with their existing antidepressant for 10 weeks. Dose will range from 10.5mg-42mg over the course of the study.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score
To evaluate whether adjunctive lumateperone reduces depressive symptoms compared with placebo.
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Eric Lenze
Lead sponsor
Washington University School of Medicine
Sponsor institution
Intra-Cellular Therapies, Inc.
Collaborator
Washington University School of Medicine
Collaborator
