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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

Study Summary

This trial tests if a new drug helps people with depression who haven't responded to other treatments.

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Asberg Depression Rating Scale
Secondary outcome measures
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

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
~1360

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
30 Previous Clinical Trials
7,061 Total Patients Enrolled
8 Trials studying Depression
4,051 Patients Enrolled for Depression

Media Library

Lumateperone 42 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05850689 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to enrolment from elderly individuals?

"This medical research is accepting volunteers that are in the 18 to 65 year old age bracket."

Answered by AI

Who is eligible to join the experiment?

"Aspiring participants to this medical trial must satisfy two criteria: they should be suffering from depression and between 18-65 years old. Currently, 470 candidates are being considered for the study."

Answered by AI

Can Lumateperone 42 mg be administered with minimal risk to patients?

"There is existing evidence that Lumateperone 42 mg is safe, so it was given a rating of 3. This evaluation was conducted based on the fact that this drug has been through clinical trials and multiple safety reviews."

Answered by AI

How many physical sites are actively engaging in this clinical trial?

"Currently, 17 sites are participating in this research study. These locations include Farmington, Clermont and Hialeah as well as 14 other places. For the convenience of potential participants, it is suggested that they pick a centre close to their residence so travelling demands can be minimized."

Answered by AI

How many participants are involved in the ongoing clinical trial?

"Affirmative. The clinicaltrials.gov website demonstrates that this experiment is presently enrolling volunteers, which was initially promoted on the 1st of May 2023 and updated as recently as April 29th 2023. 470 subjects will be recruited from 17 varied research facilities for participation in the trial."

Answered by AI

Are there any opportunities remaining to participate in this investigation?

"Affirmative. According to clinicaltrials.gov, this research endeavour which was initially advertised on May 1st 2023 is still looking for participants. Seventeen sites need 470 people in total to take part in the trial."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
New York
Other
Texas
What site did they apply to?
Clinical Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I gave up trying different med so open to try again. I've tried many drugs most barely work at best.I would love to be happy again.
PatientReceived no prior treatments
I seem to hit a ceiling with the medication I’m currently on where it stops making me feel better.
PatientReceived no prior treatments
Tried Wellbutrin, Lexapro and one other with little success. A surgical accident destroyed my mental nerve and I have chronic pain and depression.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
2023. "Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05850689.
All > Depression Los Angeles
~285 spots leftby Oct 2025
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