← Back to Search

Lumateperone for Schizophrenia

Phase 4
Recruiting
Led By Xiaoduo Fan, MD
Research Sponsored by Xiaoduo Fan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
On clozapine treatment for at least 6 months
Be older than 18 years old
Must not have
On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)
Patients not on stable dose of antipsychotic medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 6, and week 12
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing whether lumateperone can reduce side effects of clozapine, like weight gain & elevated sugar/cholesterol, for patients with schizophrenia. Participants take lumateperone/placebo and answer questions/have blood tests/body composition analysis.

Who is the study for?
This trial is for individuals with schizophrenia or schizoaffective disorder who have been on clozapine treatment for at least six months and are stable on their current antipsychotic medication. They must be compliant with outpatient medications and use birth control if applicable. People can't join if they're psychiatrically unstable, have severe medical conditions, a history of seizures, are pregnant/breastfeeding, or have used lumateperone or certain other antipsychotics recently.
What is being tested?
The study tests whether lumateperone can reduce side effects like weight gain and high sugar/cholesterol levels in patients taking clozapine. Participants will either receive lumateperone (Caplyta) or a placebo alongside their regular clozapine dose for 12 weeks while monitoring psychiatric health, blood parameters, and body composition.
What are the potential side effects?
Lumateperone may cause side effects such as sleepiness, dizziness when standing up too fast due to low blood pressure (orthostatic hypotension), restlessness (akathisia), dry mouth, changes in how the heart beats which might feel like it's skipping a beat (QT prolongation), increased saliva production or drooling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on clozapine treatment for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been on a specific antipsychotic medication in the last 3 months.
Select...
I am not on a stable dose of antipsychotic medications.
Select...
I do not have severe heart, liver, kidney, or other serious health issues.
Select...
I have a history of seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 6, and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 6, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Composition - Fat Mass
Body Composition - Fat Percentage
Body Composition - Total Body Mass
+8 more
Secondary study objectives
Calgary Depression Scale (CDRS)
Clinical Global Impression - Improvement Scale (CGI-I)
Clinical Global Impression - Severity Scale (CGI-S)
+3 more

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

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: LumateperoneExperimental 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?

Xiaoduo FanLead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
1 Trials studying Schizophrenia
6 Patients Enrolled for Schizophrenia
University of Massachusetts, WorcesterLead Sponsor
362 Previous Clinical Trials
992,670 Total Patients Enrolled
13 Trials studying Schizophrenia
737 Patients Enrolled for Schizophrenia
Intra-Cellular Therapies, Inc.Industry Sponsor
40 Previous Clinical Trials
10,682 Total Patients Enrolled
11 Trials studying Schizophrenia
2,438 Patients Enrolled for Schizophrenia
Xiaoduo Fan, MDPrincipal InvestigatorUMass Chan Medical School
1 Previous Clinical Trials
52 Total Patients Enrolled
1 Trials studying Schizophrenia
52 Patients Enrolled for Schizophrenia
~33 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top