Bipolar Disorder, ManicPhase 3NCT06462612
Study of Lumateperone in the Treatment of Patients With Bipolar Mania
A Phase 3 study testing Lumateperone in people with Bipolar Disorder, Manic, run by Intra-Cellular Therapies, Inc. at 35 sites in 4 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Disorder, Manic
- 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
- 351 participants
- Where
- 35 sitesin 4 countries
- Study dates
- 17 Jul 2024to 20 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent before the initiation of any study specific procedures;
- Male or female inpatient, between the ages of 18 and 75 years, inclusive;
- Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);
- YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline;
- Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not > 14 days before Screening. Hospital admission must be a result of the current manic episode.
Who cannot join
- Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:
- Schizophrenia, schizoaffective disorder, or other psychotic disorders;
- Dementia or other cognitive disorders;
- Intellectual disability;
- Moderate or severe substance use disorder (excluding for nicotine);
- Experiencing first manic episode;
Show all 12Show fewer
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or
- At Screening, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or
- At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or
- At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or
- At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or
- Considered to be an imminent danger to himself/herself or others.
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
United States22 sites
Clinical Site
Anaheim, California, 92805
Clinical Site
Atlanta, Georgia, 30331
Clinical Site
Bentonville, Arkansas, 72712
Clinical Site
Cerritos, California, 90703
Clinical Site
Chicago, Illinois, 60640
Clinical Site
Chicago, Illinois, 60641
Clinical Site
Cincinnati, Ohio, 45219
Clinical Site
Gaithersburg, Maryland, 20877
Clinical Site
Glen Oaks, New York, 11004
Clinical Site
Hialeah, Florida, 33012
Clinical Site
Little Rock, Arkansas, 72211
Clinical Site
Miami, Florida, 33122
Clinical Site
Miami, Florida, 33135
Clinical Site
Miami, Florida, 33145
Clinical Site
Miami Lakes, Florida, 33014
Clinical Site
Miami Lakes, Florida, 33016
Clinical Site
Orange, California, 92868
Clinical Site
Richardson, Texas, 75080
Clinical Site
Stockbridge, Georgia, 30281
Clinical Site
Tampa, Florida, 33629
Clinical Site
Torrance, California, 90504
Clinical Site
West Palm Beach, Florida, 33407
Bulgaria5 sites
Clinical Site
Burgas, 8000
Clinical Site
Kazanlak, 6100
Clinical Site
Plovdiv, 4002
Clinical Site
Sliven, 8800
Clinical Site
Sofia, 1431
Serbia5 sites
Clinical Site
Belgrade, 11000
Clinical Site
Kovin, 26220
Clinical Site
Kragujevac, 34000
Clinical Site
Niš
Clinical Site
Novi Kneževac
Romania3 sites
Clinical Site
Brasov, 507190
Clinical Site
Bucharest, 06022
Clinical Site
Iași, 700282
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, 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 3 phases:
- Screening Period (up to 1 week) during which patient eligibility will be assessed.
- Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit
- Conditions
- Bipolar Disorder, Manic
- Being tested
- Lumateperone, Placebo
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumateperoneDrug
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 | Lumateperone 42 mg capsules Receives: Drug: Lumateperone |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young Mania Rating Scale (YMRS)
The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms.
Measured: Week 3
Secondary outcomes (1)
Clinical Global Impression Scale-Severity (CGI-S)
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start17 Jul 2024
- Primary completion15 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder, ManicStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Intra-Cellular Therapies, Inc. Clinical Trial, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462612
- Sponsor's protocol ID
- ITI-007-452
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2024
- Last updated
- 24 Jul 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)
- ClinicalTrials.gov ID
- NCT06462612
- Acronym / sponsor ID
- ITI-007-452
- Conditions
- Bipolar Disorder, Manic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 17 Jun 2024 (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.
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Detailed description
The study will be conducted in 3 phases:
- Screening Period (up to 1 week) during which patient eligibility will be assessed.
- Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumateperone 42 mg | Experimental | Drug: LumateperoneLumateperone 42 mg capsules |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide written informed consent before the initiation of any study specific procedures;
- Male or female inpatient, between the ages of 18 and 75 years, inclusive;
- Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);
- YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline;
- Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not > 14 days before Screening. Hospital admission must be a result of the current manic episode.
Key exclusion criteria (12 listed)
- Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:
- Experiencing first manic episode;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or
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 |
|---|---|---|
| LumateperoneLumateperone 42 mg capsules administered orally, once daily | Drug | Lumateperone 42 mg |
| PlaceboMatching capsules administered orally, once daily | Drug | Placebo |
Primary outcome
Young Mania Rating Scale (YMRS)
Time frame: Week 3
The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms.
1 secondary outcome
Clinical Global Impression Scale-Severity (CGI-S)
Time frame: Week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 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. This study is not recruiting at the moment.
Intra-Cellular Therapies, Inc. Clinical Trial study director
Intra-Cellular Therapies, Inc.
35 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 in people with Bipolar Disorder, Manic, run by Intra-Cellular Therapies, Inc. at 35 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 5 inclusion and 12 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Bulgaria, Serbia, Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Young Mania Rating Scale (YMRS) (time frame: Week 3). 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 24 Jul 2026.