What this study is
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).
What's being tested
- Lumateperone
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
Participants 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.
Study details
- Sponsor
- Eric Lenze
- Conditions
- Treatment Resistant Depression (TRD) · Late Life Depression (LLD) · Depression / Major Depressive Disorder
- Enrolling
- 100 people
- Starts
- 2026-09-01
- Est. completion
- 2028-06
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 60 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (2)
2 openUniversity of Arizona
Tucson, Arizona, United States
- Michael Miller · Contact520-626-7117mmiller1@arizona.edu
- Kai Glahn · Contact520-621-6731xkg@arizona.edu
- Jordan Karp, MD · Principal investigator
RecruitingWashington University School of Medicine
St Louis, Missouri, United States
- Eric J Lenze, MD · Principal investigator
Recruiting
Study team
Sponsor
Eric Lenze
Study ID 202604086
Principal investigator
Eric J Lenze, MD
Washington University School of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.