Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
NCT ID: NCT06462586
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
350 participants
INTERVENTIONAL
2024-06-19
2026-04-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lumateperone 42 mg
Lumateperone 42 mg capsules
Lumateperone
Lumateperone 42 mg capsules administered orally, once daily
Placebo
Matching placebo
Placebo
Matching capsules administered orally, once daily
Interventions
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Lumateperone
Lumateperone 42 mg capsules administered orally, once daily
Placebo
Matching capsules administered orally, once daily
Eligibility Criteria
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Inclusion Criteria
2. Male or female inpatient, between the ages of 18 and 75 years, inclusive;
3. 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);
4. 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;
5. 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.
Exclusion Criteria
1. Schizophrenia, schizoaffective disorder, or other psychotic disorders;
2. Dementia or other cognitive disorders;
3. Intellectual disability;
4. Moderate or severe substance use disorder (excluding for nicotine);
2. Experiencing first manic episode;
3. 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
1. 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
2. At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or
3. 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
4. At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or
5. Considered to be an imminent danger to himself/herself or others.
18 Years
75 Years
ALL
No
Sponsors
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Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Site
Rogers, Arkansas, United States
Clinical Site
Bellflower, California, United States
Clinical Site
Culver City, California, United States
Clinical Site
Garden Grove, California, United States
Clinical Site
Lemon Grove, California, United States
Clinical Site
Montclair, California, United States
Clinical Site
Hallandale, Florida, United States
Clinical Site
Hialeah, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami Gardens, Florida, United States
Clinical Site
Miami Lakes, Florida, United States
Clinical Site
Miami Springs, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Decatur, Georgia, United States
Clinical Site
Savannah, Georgia, United States
Clinical Site
Shreveport, Louisiana, United States
Clinical Site
Marlton, New Jersey, United States
Clinical Site
North Canton, Ohio, United States
Clinical Site
Austin, Texas, United States
Clinical Site
Austin, Texas, United States
Clinical Site
DeSoto, Texas, United States
Clinical Site
Lovech, , Bulgaria
Clinical Site
Rousse, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Stara Zagora, , Bulgaria
Clinical Site
Veliko Tarnovo, , Bulgaria
Clinical Site
Vratsa, , Bulgaria
Clinical Site
Split, , Croatia
Clinical Site
Zagreb, , Croatia
Clinical Site
Zagreb, , Croatia
Clinical Site
Guwahati, Assam, India
Clinical Site
Mangalore, Karnataka, India
Clinical Site
Mysore, Karnataka, India
Clinical Site
Nashik, Maharashtra, India
Clinical Site
Ludhiana, Punjab, India
Clinical Site
Belgrade, , Serbia
Clinical Site
Kovin, , Serbia
Clinical Site
Kragujevac, , Serbia
Clinical Site
Novi Kneževac, , Serbia
Clinical Site
Novi Sad, , Serbia
Countries
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Central Contacts
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Other Identifiers
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ITI-007-451
Identifier Type: -
Identifier Source: org_study_id
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