Lumateperone added to antidepressant therapy for older adults with treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 10-week, randomized, double-blind, placebo-controlled study in about 100 older adults with unipolar major depressive disorder and treatment resistance. Participants will continue their current antidepressant at a stable dose and be assigned to lumateperone or placebo as an add-on therapy. The study includes screening, baseline cognitive and mood assessments, a physical exam, and safety monitoring, with outcomes focused on mood improvement and tolerability. Two sites, at Washington University in St. Louis and the University of Arizona, will recruit participants aged 60 or older. Lead sponsor is Eric Lenze, with collaborators Intra-Cellular Therapies and Washington University School of Medicine.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Eric J Lenze, MD — Washington University School of Medicine
• Study coordinator: Angela Stevens
• Email: stevens.a@wustl.edu
• Phone: 314-362-6291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.