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Lumateperone for Major Depressive Disorder

Phase 3
Recruiting
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 43
Awards & highlights
Pivotal Trial

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects of Lumateperone in this context aren't detailed here, common ones may include drowsiness, restlessness, nausea, dry mouth and changes in weight or appetite. Side effects can vary widely among individuals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 43 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Montgomery-Asberg Depression Rating Scale
Secondary study objectives
Clinical Global Impression Scale-Severity

Side effects data

From 2019 Phase 3 trial • 381 Patients • NCT03249376
18%
Headache
9%
Somnolence
6%
Nauseau
5%
Dizziness
1%
Mania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumateperone
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lumateperone 42 mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumateperone
2021
Completed Phase 3
~2650

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
40 Previous Clinical Trials
10,262 Total Patients Enrolled
8 Trials studying Depression
4,113 Patients Enrolled for Depression

Media Library

Lumateperone 42 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05850689 — Phase 3
~241 spots leftby Sep 2026
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