Lumateperone for Major Depressive Disorder

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Intra-Cellular Therapies, Inc.

Must be taking: Antidepressants

Disqualifiers: Schizophrenia, Bipolar, Anxiety, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing lumateperone, a medication that may help people with depression who haven't improved with other treatments. The study includes patients diagnosed with Major Depressive Disorder who haven't responded well to their current antidepressants. Lumateperone works by balancing brain chemicals that affect mood, potentially improving depressive symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have an inadequate response to at least two antidepressants and continue taking one of them at the minimum effective dose for at least six weeks.

Is Lumateperone safe for humans?

Lumateperone has shown a favorable safety profile in clinical trials, with no significant side effects like movement disorders, hormonal changes, or heart-related issues compared to a placebo. ^{1 2 3 4 5}

How is the drug lumateperone different from other treatments for major depressive disorder?

Lumateperone is unique because it is a first-in-class drug that simultaneously affects serotonin, dopamine, and glutamate systems in the brain, which is different from most other treatments that typically target only one or two of these pathways. It is also taken orally and has been shown to improve a wide range of depression symptoms in people with bipolar disorder, suggesting potential benefits for major depressive disorder. ^{3 5 6 7 8}

Research Team

Eligibility Criteria

This trial is for adults aged 18-65 with Major Depressive Disorder (MDD) who haven't had enough improvement from their current antidepressant treatment. They must have been on a stable dose of certain antidepressants for at least 6 weeks and meet specific criteria indicating moderate to severe depression.

Inclusion Criteria

My depression hasn't improved much with current medication, despite taking it as prescribed for over 6 weeks.

I have been diagnosed with major depression, including with psychotic features.

I am between 18 and 65 years old.

Exclusion Criteria

Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including specified disorders

In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or meets specified criteria

The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 2 weeks

Treatment

Participants receive either placebo or lumateperone 42 mg/day in a double-blind manner

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Lumateperone (Other)
• Placebo (Placebo)

Trial Overview The study tests Lumateperone as an additional treatment alongside existing antidepressant therapy (ADT) compared to a placebo, in patients with MDD who are not responding well to their current ADT. It's a multicenter, randomized, double-blind trial ensuring neither participants nor researchers know who receives the actual drug or placebo.

Participant Groups

Group I: Lumateperone 42 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Clinical Site Kansas City, KS

Clinical Site Pico Rivera, CA

Clinical Site Philadelphia, PA

Clinical Site Clermont, FL

More Trial Locations

Who Is Running the Clinical Trial?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials

42

Patients Recruited

10,700+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumateperone: a new treatment approach for neuropsychiatric disorders. Kumar, B., Kuhad, A., Kuhad, A.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence on the New Drug Lumateperone (ITI-007) for Psychiatric and Neurological Disorders. Mazza, M., Marano, G., Traversi, G., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumateperone: New Drug or Same Old Drug With a New Dress? Limandri, BJ.[2021]

In a phase 3 study involving 377 patients with bipolar I or II disorder, lumateperone at 42 mg/day significantly improved depression symptoms compared to placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impressions Scale-Bipolar Version (CGI-BP-S).

Lumateperone was generally well tolerated, with only somnolence and nausea occurring at a higher rate than placebo, and a low incidence of extrapyramidal symptoms, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. Calabrese, JR., Durgam, S., Satlin, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumateperone: First Approval. Blair, HA.[2021]

In a study of 376 adults with bipolar I or II disorder experiencing a major depressive episode, lumateperone 42 mg significantly improved depression symptoms and overall disease severity compared to placebo, regardless of the presence of mixed features.

The treatment was well-tolerated, with rare occurrences of treatment-emergent adverse events related to mania or hypomania, indicating a favorable safety profile for lumateperone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Lumateperone in Patients With Bipolar Depression With Mixed Features. McIntyre, RS., Durgam, S., Huo, J., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of lumateperone on symptoms of depression in bipolar I and bipolar II disorder: Secondary and post hoc analyses. McIntyre, RS., Durgam, S., Kozauer, SG., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating lumateperone for its use in treating depressive episodes associated with bipolar I or II disorder in adults. Abuelazm, H., Elsayed, OH., El-Mallakh, RS.[2023]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Lumateperone: a new treatment approach for neuropsychiatric disorders. [2019]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Evidence on the New Drug Lumateperone (ITI-007) for Psychiatric and Neurological Disorders. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Lumateperone: New Drug or Same Old Drug With a New Dress? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Lumateperone: First Approval. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Lumateperone in Patients With Bipolar Depression With Mixed Features. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The efficacy of lumateperone on symptoms of depression in bipolar I and bipolar II disorder: Secondary and post hoc analyses. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Evaluating lumateperone for its use in treating depressive episodes associated with bipolar I or II disorder in adults. [2023]