Lumateperone for Late-Life Depression
Lumateperone for Late-Life Depression
Recruiting
Phase 3
Interventional Study
Treatment Resistant Depression (TRD)
Late Life Depression (LLD)
Depression / Major Depressive Disorder
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 60 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Eric Lenze · Other
Who this trial is looking for
This trial is looking for older adults with depression that hasn't improved after trying other treatments. Participants will take either the medication lumateperone or a placebo pill to see how it helps their depression.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 60 years old
- I have been diagnosed with major depression
- I have a MADRS score of 20 or higher
- I have not responded to at least two antidepressant medications
- I am currently taking an antidepressant for at least six weeks
- I have a MMSE score of 24 or higher
You may not be able to join if
- I have dementia
- I have a high risk for suicide
- I have a high risk for alcohol use
- My doctor says I cannot participate safely in this trial
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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 (Capl…
Trial Locations
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Eligibility Criteria
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 e…
Contacts