LUMATEPERONE FOR LATE-LIFE DEPRESSION
This 10-week double blind, placebo-controlled clinical trial will test the efficacy and safety of lumateperone in 100 older adults with treatment resistant depression (TRD) across two sites. Lumateperone is a multi- modal antipsychotic with preferential 5-HT2A blockade. It has received FDA-approval in November 2025for adjunctive treatment of Major Depressive Disorder in adults.
Study phase: II
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Adults aged 60 or older with unipolar major depressive disorder and screening MADRS score >=20 who have not responded to two oral antidepressant medications in current or previous episode, is currently taking an antidepressant medication of adequate dose and duration, and has MMSE score >/=24. Participants who may not have had two oral antidepressants in current or previous episode but are determined t meet clinical criteria and consensus agreement for treatment resistance (i.e., history of sequential trials of antidepressants +/- augmentation) may also be included.
Primary disease category: Mental Health
This study is enrolling healthy volunteers.
Sponsor: Intra-cellular Therapies
Protocol number: STUDY00007768
Projected enrollment dates: June 2026 to November 2028
Official study title: Lumateperone for Late-Life Depression