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Lumateperone for Late-Life Depression

RecruitingPhase 3Ages 60 Years - anyAllEric Lenze
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 * Currently taking oral antidepressant prescribed at least minimum therapeutic dose and for at least six weeks duration * MMSE score of \>/=24 Exclusion Criteria: * 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.
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What it tests

  • Lumateperone
  • Placebo
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Where

2 sites
University of Arizona
Tucson, United States
Washington University School of Medicine
St Louis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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