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RecruitingPhase 3

Lumateperone for Late-Life Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit
  • Procedures mentioned: Physical exams, Questionnaires, Blood draws, Heart tracing (ECG), Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This will involve answering questions and completing questionnaires about mood and emotions, completing tasks on an iPad to assess thinking, attention, and memory, as well as a physical exam."
  • "The physical exam will include gathering height and weight, an evaluation for potential medication side effects, a fasting blood draw to measure blood lipids and glucose, and an electrocardiogram (ECG). * Study Medication: Participants will be randomized (like flipping a coin) to take either lumateperone or placebo (sugar pill)."
  • "This visit includes answering questions and completing questionnaires about mood and emotions, medication changes, and side effects."
  • "There will also be a fasting blood draw to measure blood lipids and glucose as well as another ECG. * Extra visit (if needed): The study team may ask participants to complete one additional endpoint visit for a final assessment of symptoms."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether lumateperone (Caplyta) helps relieve depression in adults age 60 and older whose depression has not improved with treatment. It compares lumateperone with a placebo, a sugar pill with no medicine.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 60 or older.
  • A study interview confirms current major depression, without bipolar disorder or symptoms like seeing or hearing things that are not there.
  • Your depression rating score (MADRS) is at least 20 at screening and at least 18 at the start of the study.
  • At least two medicines taken by mouth did not help your depression, despite taking enough for long enough, during this or a past period of depression. Or, your clinician thinks adding a medicine is right for you.
  • You currently take an antidepressant by mouth and have taken at least the lowest treatment dose for six weeks or longer.
  • Your score on a memory and thinking test (MMSE) is at least 24.

Who can't join

  • You have dementia, a condition that affects memory and thinking.
  • You have a high suicide risk, with current or recent intent or a plan, and cannot be kept safe in the study. The study team will refer you for urgent mental health care.
  • Your alcohol screening score (AUDIT-C) is 6 or higher, showing high-risk drinking.
  • The lead study doctors decide that taking part is not medically appropriate for you.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (2)

AZ

MO

  • Washington University School of Medicine · St Louis, MO 63110Eric J Lenze, MD · Principal investigatorMore trials in St Louis