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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 6, and week 12
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Composition - Fat Mass
Body Composition - Fat Percentage
Body Composition - Total Body Mass
+8 more
Secondary outcome measures
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

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
~1360

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
343 Previous Clinical Trials
986,560 Total Patients Enrolled
13 Trials studying Schizophrenia
737 Patients Enrolled for Schizophrenia
Intra-Cellular Therapies, Inc.Industry Sponsor
30 Previous Clinical Trials
7,481 Total Patients Enrolled
10 Trials studying Schizophrenia
2,338 Patients Enrolled for Schizophrenia

Frequently Asked Questions

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

Is this clinical trial inclusive of individuals aged 40 and above?

"The parameters of this trial require that prospective participants must be at least 18 years old and no older than 65."

Answered by AI

Has Lumateperone been officially sanctioned by the Federal Drug Administration?

"A score of 3 was assigned to lumateperone's safety due to it having been approved by the end of Phase 4 trials."

Answered by AI

Are there any remaining vacancies for participants in this trial?

"As per the information displayed on clinicaltrials.gov, this medical trial is looking for volunteers and has been actively advertised since December 1st 2023 with some modifications made to its initial design as recently as December 8th of the same year."

Answered by AI

To what type of individuals is enrollment in this trial open?

"This schizoaffective disorder study is accepting 50 people aged between 18 and 65. To be accepted, a patient must meet the age criteria and suffer from this particular illness."

Answered by AI

In what capacity is the patient population being studied in this clinical research?

"Affirmative. As seen on clinicaltrials.gov, the study opened for recruitment on December 1st 2023 and was recently updated on the 8th. 50 individuals are expected to join at one research centre across the country."

Answered by AI

What is the intended outcome of this clinical research?

"This clinical trial will use Body Composition - Fat Mass to measure its efficacy in a two-week period. Secondary criteria assessed include the Henrichs Carpenter Quality of Life Scale (QLS), Calgary Depression Scale (CDRS) and Clinical Global Impression – Severity scale (CGI-S). The QLS is a 21 item assessment to evaluate symptoms and functioning, CDRS grades depression severity, while CGI-S uses an observer rated 7 point Likert scale to judge illness extremeness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Xiaoduo Fan 2024. "Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06174116.
~33 spots leftby Aug 2026
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