SchizophreniaPhase 3NCT04959032
Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
A Phase 3 study testing Lumateperone 42 mg in people with Schizophrenia, run by Intra-Cellular Therapies, Inc. at 43 sites in 4 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lumateperone 42 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 592 participants
- Where
- 43 sitesin 4 countries
- Study dates
- 8 Jul 2021to 7 Aug 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, 18 to 60 years of age, inclusive.
- Current diagnosis of schizophrenia according to DSM-5 criteria as determined by the modified Structured Clinical Interview for DSM-5 (modified SCID-5).
- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1.
- Current psychotic episode < 4 weeks duration at Visit 1.
- PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2.
- Rating of at least 4 (moderate) on at least two of the following four PANSS positive symptoms: delusions (P1), hallucinatory behavior (P3), conceptual disorganization (P2), suspiciousness/persecution (P6) at Visit 1 and Visit 2.
- Patient must identify a caregiver who provides consents to participate in the study.
- In the opinion of the Investigator, the patient has significant risk for suicidal behavior during the course of his/her participation in the study.
Who cannot join
- Currently meeting DSM-5 criteria for any of the following:
- Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders; Bipolar I or Bipolar II Disorder; Intellectual developmental disorder, delirium, dementia, amnestic and other cognitive disorders; Known or suspected borderline or antisocial personality disorder or other DSM 5 personality disorder of sufficient severity to interfere with participation in this study; Substance use disorder (other than nicotine) within the 3 months prior to Visit 1 of this study.
- Patients in their first episode of psychosis.
- Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the package insert for the antipsychotic treatment).
Trial locations and contacts
43 sites in 4 countries.
43 sites in 4 countries
United States21 sites
Clinical Site
Atlanta, Georgia, 30331
Clinical Site
Austin, Texas, 78754
Clinical Site
Bellflower, California, 907006
Clinical Site
Berlin, New Jersey, 08009
Clinical Site
Boston, Massachusetts, 02114
Clinical Site
Cerritos, California, 90703
Clinical Site
Chicago, Illinois, 60640
Clinical Site
Culver City, California, 90230
Clinical Site
DeSoto, Texas, 75115
Clinical Site
Garden Grove, California, 92845
Clinical Site
Hollywood, Florida, 33021
Clinical Site
Las Vegas, Nevada, 89102
Clinical Site
Lemon Grove, California, 91945
Clinical Site
Little Rock, Arkansas, 72211
Clinical Site
Miami Lakes, Florida, 33016
Clinical Site
Montclair, California, 91763
Clinical Site
North Canton, Ohio, 44720
Clinical Site
Oakland Park, Florida, 33334
Clinical Site
Orange, California, 92869
Clinical Site
Richardson, Texas, 75080
Clinical Site
St Louis, Missouri, 63141
Bulgaria14 sites
Clinical Site
Burgas, 8000
Clinical Site
Kardzhali, 6600
Clinical Site
Kazanlak, 6100
Clinical Site
Lovech, 5500
Clinical Site
Novi Iskar, 1282
Clinical Site
Pleven, 5800
Clinical Site
Plovdiv, 4002
Clinical Site
Rousse, 7003
Clinical Site
Sofia, 1377
Clinical Site
Targovishte, 7700
Clinical Site
Tsarev Brod, 9747
Clinical Site
Tserova Koria, 5047
Clinical Site
Veliko Tarnovo, 5000
Clinical Site
Vratsa, 3000
Poland4 sites
Clinical Site
Gdansk, 80-214
Clinical Site
Gdansk, 80-282
Clinical Site
Gorlice, 3-8300
Clinical Site
Tuszyn, 95080
Serbia4 sites
Clinical site
Belgrade, 11000
Clinical Site
Kovin, 26220
Clinical Site
Kragujevac, 34000
Clinical Site
Novi Kneževac, 23330
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).
Read the detailed description
The study will be conducted in the following 5 phases:
- A no-drug Screening Phase up to 7 days in duration during which patient eligibility will be assessed;
- A 6-week, open-label Run-in Phase (RIP) during which all patients will receive oral lumateperone 42 mg/day;
- A 12-week, open-label Stabilization Phase (SP) during which all patients will receive oral lumateperone 42 mg/day;
- A Double-blind Treatment Phase (DBTP) 26 weeks in duration during which patients receive either lumateperone 42 mg or placebo (1:1 ratio);
- A 2-week Safety Follow-up (SFU) Phase.
- Conditions
- Schizophrenia
- Being tested
- Lumateperone 42 mg, Placebo
- Keywords
- Schizophrenia, Relapse Prevention, Maintenance Design
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumateperone 42 mgDrug
Lumateperone 42 mg capsules administered orally, once daily.
PlaceboDrug
Matching capsules administered orally, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone 42 mg | Experimental | Not described Receives: Drug: Lumateperone 42 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Symptom Relapse During the Double-blind Treatment Phase
Relapse during the DBTP was defined as meeting any one of the following criteria:
- Psychiatric hospitalization or need for increased level of psychiatric care due to worsening of the patient's underlying condition;
- Increase in PANSS total score by ≥ 30% for patients who scored 50 or higher at randomization or a 10-point or more increase in PANSS total score for patients who scored less than 50 at randomization ;
- Increase in the Visit 14 CGI-S score by 2 or more points;
- Deliberate self-injury or aggressive/violent behavior;
- Any suicidal ideation or homicidal ideation;
- Score of greater than 4 on 1 or more of the following PANSS items: P1, P2, P3, P6, P7, G8 or G14
Measured: Number of days from the randomization date to the first relapse date up to 26 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start8 Jul 2021
- Primary completion25 Jul 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Intra-Cellular Therapies, Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959032
- Sponsor's protocol ID
- ITI-007-304
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2021
- Last updated
- 5 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT04959032
- Acronym / sponsor ID
- ITI-007-304
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Relapse Prevention, Maintenance Design
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 5 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).
Detailed description
The study will be conducted in the following 5 phases:
- A no-drug Screening Phase up to 7 days in duration during which patient eligibility will be assessed;
- A 6-week, open-label Run-in Phase (RIP) during which all patients will receive oral lumateperone 42 mg/day;
- A 12-week, open-label Stabilization Phase (SP) during which all patients will receive oral lumateperone 42 mg/day;
- A Double-blind Treatment Phase (DBTP) 26 weeks in duration during which patients receive either lumateperone 42 mg or placebo (1:1 ratio);
- A 2-week Safety Follow-up (SFU) Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumateperone 42 mg | Experimental | Drug: Lumateperone 42 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female, 18 to 60 years of age, inclusive.
- Current diagnosis of schizophrenia according to DSM-5 criteria as determined by the modified Structured Clinical Interview for DSM-5 (modified SCID-5).
- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1.
- Current psychotic episode < 4 weeks duration at Visit 1.
- PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2.
Key exclusion criteria (4 listed)
- Currently meeting DSM-5 criteria for any of the following:
- Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders; Bipolar I or Bipolar II Disorder; Intellectual developmental disorder, delirium, dementia, amnestic and other cognitive disorders; Known or suspected borderline or antisocial personality disorder or other DSM 5 personality disorder of sufficient severity to interfere with participation in this study; Substance use disorder (other than nicotine) within the 3 months prior to Visit 1 of this study.
- Patients in their first episode of psychosis.
- Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the package insert for the antipsychotic treatment).
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 |
|---|---|---|
| Lumateperone 42 mgLumateperone 42 mg capsules administered orally, once daily. | Drug | Lumateperone 42 mg |
| PlaceboMatching capsules administered orally, once daily. | Drug | Placebo |
Primary outcome
Time to First Symptom Relapse During the Double-blind Treatment Phase
Time frame: Number of days from the randomization date to the first relapse date up to 26 weeks.
Relapse during the DBTP was defined as meeting any one of the following criteria: * Psychiatric hospitalization or need for increased level of psychiatric care due to worsening of the patient's underlying condition; * Increase in PANSS total score by ≥ 30% for patients who scored 50 or higher at randomization or a 10-point or more increase in PANSS total score for patients who scored less than 50 at randomization ; * Increase in the Visit 14 CGI-S score by 2 or more points; * Deliberate self-injury or aggressive/violent behavior; * Any suicidal ideation or homicidal ideation; * Score of greater than 4 on 1 or more of the following PANSS items: P1, P2, P3, P6, P7, G8 or G14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumateperone 42 mg in people with Schizophrenia, run by Intra-Cellular Therapies, Inc. at 43 sites in 4 countries.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Bulgaria, Poland, Serbia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Symptom Relapse During the Double-blind Treatment Phase (time frame: Number of days from the randomization date to the first relapse date up to 26 weeks.). 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 5 Oct 2026.