SchizophreniaPhase 4NCT06174116
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
A Phase 4 study testing Lumateperone in people with Schizophrenia and Schizo Affective Disorder, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder
- What is being tested?
- Lumateperone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0)
- On clozapine treatment for at least 6 months
- Stable dose of antipsychotic treatment for at least 1 month
- Well established compliance with outpatient medications
- Subjects of child-bearing potential are required to practice appropriate birth control methods during the study.
Who cannot join
- Psychiatrically unstable per clinical judgement by the principal investigator
- Patients not on stable dose of antipsychotic medications
- Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine
- Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases
- History of a seizure disorder
- Pregnancy or breastfeeding
- On lumateperone treatment in the past 3 months
- On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMass Chan Medical School
Worcester, Massachusetts, 01655
Abaigeal Grant, 508-856-3027, abaigeal.grant2@umassmed.edu
Xiaoduo Fan, MD, MPH
About this study
The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol.
Participants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).
Read the detailed description
This is a 12-week study in which we investigate how adjunctive lumateperone affects lipid particle size and body composition in clozapine-treated patients with schizophrenia; in addition, we will investigate if lumateperone improves insomnia. Outcome measures will record a variety of assessments related to participants' psychiatric symptoms, psychosocial functioning, and biological outcomes.
- Conditions
- Schizophrenia, Schizo Affective Disorder
- Being tested
- Lumateperone, Placebo
- Keywords
- Clozapine
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumateperoneDrug
Also called Caplyta
Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.
PlaceboDrug
Subject will take placebo for 12 weeks, in addition to their regular medications.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 Placebo capsules taken orally per day for 12 weeks Receives: Drug: Placebo |
| Lumateperone | Experimental | 42mg (two 21mg capsules) lumateperone (Caplyta) taken orally per day for 12 weeks Receives: Drug: Lumateperone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Participant Body Mass Index will be measured by standard methods
Measured: Week 0, Week 6, and Week 12
Waist Circumference
Participant Waist Circumference will be measured by standard methods
Measured: Week 0, Week 6, and Week 12
Body Composition - Fat Mass
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat mass will be measured in grams.
Measured: Week 0 and Week 12
Body Composition - Total Body Mass
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Total Body Mass will be measured in grams.
Measured: Week 0 and Week 12
Body Composition - Fat Percentage
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat Percentage will be calculated as fat mass (in grams) divided by total mass (in grams).
Measured: Week 0 and Week 12
HBA1C
Participant HBA1C will be measured using standard labs
Measured: Week 0 and Week 12
Fasting Insulin
Participant Fasting Insulin will be measured using standard labs
Measured: Week 0, Week 6, and Week 12
LDL Particle
LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Measured: Week 0 and Week 12
Small LDL Particle
Small LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Measured: Week 0 and Week 12
Large HDL Particle
Large HDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Measured: Week 0 and Week 12
Large VLDL Particle
Large VLDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Measured: Week 0 and Week 12
Secondary outcomes (6)
Positive and Negative Symptoms Scale (PANSS)
PANSS is a measure used to assess symptom severity in patients with schizophrenia. It consists of three sections: Positive scale has 7 items, Negative scale has 7 items, and General Psychopathology has 16 items. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme.
Measured: Week 0, Week 6, and Week 12
Calgary Depression Scale (CDRS)
The CDRS is used to assess depression symptoms in patients with schizophrenia.
Measured: Week 0, Week 6, and Week 12
Clinical Global Impression - Severity Scale (CGI-S)
The CGI-S is an observer rated scale. The CGI-S measures illness severity on a 7-point Likert scale 1) Normal, not at all ill, 2) Borderline mentally ill, 3) Mildly ill, 4) Moderately ill, 5) Markedly ill, 6) Severely ill, and 7) Among the most extremely ill patient.
Measured: Week 0, Week 6, and Week 12
Clinical Global Impression - Improvement Scale (CGI-I)
The CGI-I is an observer rated scale. The CGI-I is used to measure improvement in illness and uses a 7-point Likert scale: 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change 5) Minimally worse, 6) Much worse, 7) Very much worse.
Measured: Week 0, Week 6, and Week 12
Insomnia Severity Index (ISI)
The ISI is a 7-question survey assessing symptoms of insomnia. The maximum score is 28 with higher scores indicating greater severity. The ISI is a reliable and valid instrument to assess insomnia and treatment response.
Measured: Week 0, Week 6, and Week 12
Henrichs Carpenter Quality of Life Scale (QLS)
The QLS is a 21-item scale providing information on symptoms and functioning in patients with schizophrenia.
Measured: Week 0, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start2 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Intra-Cellular Therapies, Inc.
- Responsible party
- Principal investigator, Xiaoduo Fan, MD, MPH, University of Massachusetts, Worcester
- Investigators
- Xiaoduo Fan, MD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174116
- Sponsor's protocol ID
- STUDY00001339
- Status last verified
- May 2026
- First submitted
- 8 Dec 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT06174116
- Acronym / sponsor ID
- STUDY00001339
- Conditions
- Schizophrenia, Schizo Affective Disorder
- Keywords
- Clozapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Intra-Cellular Therapies, Inc.
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol.
Participants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).
Detailed description
This is a 12-week study in which we investigate how adjunctive lumateperone affects lipid particle size and body composition in clozapine-treated patients with schizophrenia; in addition, we will investigate if lumateperone improves insomnia. Outcome measures will record a variety of assessments related to participants' psychiatric symptoms, psychosocial functioning, and biological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo2 Placebo capsules taken orally per day for 12 weeks |
| Lumateperone | Experimental | Drug: Lumateperone42mg (two 21mg capsules) lumateperone (Caplyta) taken orally per day for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0)
- On clozapine treatment for at least 6 months
- Stable dose of antipsychotic treatment for at least 1 month
- Well established compliance with outpatient medications
- Subjects of child-bearing potential are required to practice appropriate birth control methods during the study.
Key exclusion criteria (8 listed)
- Psychiatrically unstable per clinical judgement by the principal investigator
- Patients not on stable dose of antipsychotic medications
- Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine
- Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases
- History of a seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumateperoneAlso: CaplytaSubject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications. | Drug | Lumateperone |
| PlaceboSubject will take placebo for 12 weeks, in addition to their regular medications. | Drug | Placebo |
Primary outcome
Body Mass Index (BMI)
Time frame: Week 0, Week 6, and Week 12
Participant Body Mass Index will be measured by standard methods
Waist Circumference
Time frame: Week 0, Week 6, and Week 12
Participant Waist Circumference will be measured by standard methods
Body Composition - Fat Mass
Time frame: Week 0 and Week 12
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat mass will be measured in grams.
Body Composition - Total Body Mass
Time frame: Week 0 and Week 12
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Total Body Mass will be measured in grams.
Body Composition - Fat Percentage
Time frame: Week 0 and Week 12
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat Percentage will be calculated as fat mass (in grams) divided by total mass (in grams).
HBA1C
Time frame: Week 0 and Week 12
Participant HBA1C will be measured using standard labs
Fasting Insulin
Time frame: Week 0, Week 6, and Week 12
Participant Fasting Insulin will be measured using standard labs
LDL Particle
Time frame: Week 0 and Week 12
LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Small LDL Particle
Time frame: Week 0 and Week 12
Small LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Large HDL Particle
Time frame: Week 0 and Week 12
Large HDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Large VLDL Particle
Time frame: Week 0 and Week 12
Large VLDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
6 secondary outcomes
Positive and Negative Symptoms Scale (PANSS)
Time frame: Week 0, Week 6, and Week 12
Calgary Depression Scale (CDRS)
Time frame: Week 0, Week 6, and Week 12
Clinical Global Impression - Severity Scale (CGI-S)
Time frame: Week 0, Week 6, and Week 12
Clinical Global Impression - Improvement Scale (CGI-I)
Time frame: Week 0, Week 6, and Week 12
Insomnia Severity Index (ISI)
Time frame: Week 0, Week 6, and Week 12
Henrichs Carpenter Quality of Life Scale (QLS)
Time frame: Week 0, Week 6, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoduo Fan, MD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumateperone in people with Schizophrenia and Schizo Affective Disorder, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abaigeal Grant, BA (5088563027, abaigeal.grant2@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: Week 0, Week 6, and Week 12). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.