Lumateperone for Depression
(IRL Grey-C Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called lumateperone (Caplyta) to determine its effectiveness in relieving depression in older adults who haven't found success with other treatments. Lumateperone is already approved for use with other antidepressants in adults. The trial compares lumateperone to a placebo (a pill with no medication) to assess its effectiveness. The study seeks participants aged 60 and older who are currently dealing with major depression and haven't responded well to at least two other medications. Participants must already be taking an antidepressant prescribed at a therapeutic dose for at least six weeks. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
No, you don't have to stop taking your current antidepressant medication. The trial requires participants to continue taking their existing antidepressant while adding lumateperone (Caplyta).
Is there any evidence suggesting that lumateperone is likely to be safe for humans?
Research has shown that lumateperone, also known as Caplyta, is generally safe and well tolerated. In earlier studies, participants taking lumateperone experienced side effects such as dizziness, dry mouth, and drowsiness more frequently than those taking a placebo (a pill with no medicine). However, serious side effects were rare.
The FDA has already approved lumateperone for treating depression when used with another antidepressant, further supporting its safety. Some trials have demonstrated that its safety profile is similar to that of a placebo. Overall, evidence suggests that lumateperone is a safe option for managing depression, with most people tolerating it well.12345Why do researchers think this study treatment might be promising?
Lumateperone is unique because it offers a novel approach to treating depression. Unlike many standard treatments that target serotonin pathways, lumateperone acts on multiple neurotransmitter systems, including serotonin, dopamine, and glutamate. This multi-faceted mechanism might provide a more comprehensive effect on mood regulation. Researchers are excited about lumateperone's potential for fewer side effects and a faster onset of action compared to traditional antidepressants, which often take weeks to become effective.
What evidence suggests that lumateperone might be an effective treatment for depression?
Research has shown that lumateperone (Caplyta) helps treat depression. One study found that participants taking lumateperone experienced a noticeable improvement in their depression symptoms compared to those taking a placebo (a pill with no active medicine). Specifically, their depression scores dropped by 14.7 points over six weeks, while the placebo group saw a 10.2-point drop. Another study found that combining lumateperone with another antidepressant also significantly improved depression symptoms and the severity of the condition. Overall, lumateperone has consistently helped improve symptoms in people with depression that hasn't responded to other treatments.13678
Who Is on the Research Team?
Eric J Lenze, MD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for older adults who have depression that hasn't improved with other treatments. Participants should be diagnosed with major depressive disorder and currently taking an antidepressant, but still experiencing symptoms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Eligible participants complete a baseline visit involving questionnaires, cognitive tasks, and a physical exam
Treatment
Participants receive either lumateperone or placebo adjunctively with their existing antidepressant medication
Endpoint
Participants complete an endpoint visit to assess the effects of lumateperone or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lumateperone
Trial Overview
The study compares lumateperone (Caplyta), a medication approved for depression, to a placebo (inactive pill) in older adults. The goal is to see if lumateperone helps relieve depression when added to current treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The starting dose of lumateperone or placebo will typically be 21 mg/day for the first week. Those participants who are taking moderate or strong CYP3A4 inhibitors will start at 10.5 mg/ day. The dose will be increased for most participants to 42 mg/ day at Week 2 and maintained until Week 10. Participants with moderate or severe hepatic impairment (Child-Pugh class B or C) will be maintained at 21 mg/day. Participants who are taking strong CYP3A4 inhibitors will be maintained at 10.5 mg/ day. Participants who are taking moderate CYP3A4 inhibitors will increase as tolerated to 21 mg/ day.
The starting dose of lumateperone or placebo will typically be 21 mg/day for the first week. Those participants who are taking moderate or strong CYP3A4 inhibitors will start at 10.5 mg/ day. The dose will be increased for most participants to 42 mg/ day at Week 2 and maintained until Week 10. Participants with moderate or severe hepatic impairment (Child-Pugh class B or C) will be maintained at 21 mg/day. Participants who are taking strong CYP3A4 inhibitors will be maintained at 10.5 mg/ day. Participants who are taking moderate CYP3A4 inhibitors will increase as tolerated to 21 mg/ day.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eric Lenze
Lead Sponsor
Intra-Cellular Therapies, Inc.
Industry Sponsor
Washington University School of Medicine
Collaborator
Citations
Lumateperone monotherapy for major depressive episodes ...
This Phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of lumateperone to treat bipolar depression.
CAPLYTA® (lumateperone) showed greatest improvement ...
The NMA found that CAPLYTA® was favored for the efficacy outcomes across four measures, based on indirect comparisons derived from placebo plus ...
3.
psychiatrist.com
psychiatrist.com/jcp/lumateperone-adjunctive-therapy-major-depressive-disorder-randomized-double-blind-phase-3-trial/Lumateperone as Adjunctive Therapy in Patients With ...
Conclusions: Lumateperone 42 mg adjunctive to ADT significantly improved depression symptoms and disease severity vs adjunctive placebo and was ...
Primary Data: MADRS Total Score | CAPLYTA® (lumateperone)
In Study 502, patients on CAPLYTA saw a 14.7-point reduction at 6 weeks compared to 10.2-point reduction with placebo (placebo-subtracted difference of 4.5; P< ...
The efficacy of lumateperone on symptoms of depression ...
Lumateperone 42 mg treatment significantly improved depression symptoms compared with placebo, with consistent efficacy across a broad range of symptoms.
Long-Term Safety Data | CAPLYTA® (lumateperone)
Major Depressive Disorder (Adjunctive therapy): dizziness (17% vs 5%), dry mouth (13% vs 3%), somnolence/sedation (12% vs 2%), nausea (9% vs 4%), fatigue (8% vs ...
FDA approval of CAPLYTA® (lumateperone) has the ...
safety profile was consistent with pivotal studies and 80% of MDD patients taking CAPLYTA® achieved response, with 65% of patients reaching ...
A NETWORK META-ANALYSIS
Safety outcomes included ≥7% weight increase from baseline, akathisia, and somnolence. Fixed-effect Bayesian NMAs were conducted. Treatment effects versus ...
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