NCT06462612

Brief 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 Manual of Mental Disorders, Fifth Edition (DSM 5).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P50-P75 for phase_3

Timeline
1mo left

Started Jul 2024

Geographic Reach
4 countries

35 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2024Jun 2026

First Submitted

Initial submission to the registry

June 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 17, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

June 12, 2024

Last Update Submit

June 27, 2025

Conditions

Bipolar Disorder, Manic

Outcome Measures

Primary Outcomes (1)

  • 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.

    Week 3

Secondary Outcomes (1)

  • Clinical Global Impression Scale-Severity (CGI-S)

    Week 3

Study Arms (2)

Lumateperone 42 mg

EXPERIMENTAL

Lumateperone 42 mg capsules

Drug: Lumateperone

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

LumateperoneDRUG

Lumateperone 42 mg capsules administered orally, once daily

Lumateperone 42 mg
PlaceboDRUG

Matching capsules administered orally, once daily

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Clinical Site

Bentonville, Arkansas, 72712, United States

RECRUITING

Clinical Site

Little Rock, Arkansas, 72211, United States

RECRUITING

Clinical Site

Anaheim, California, 92805, United States

RECRUITING

Clinical Site

Cerritos, California, 90703, United States

RECRUITING

Clinical Site

Orange, California, 92868, United States

RECRUITING

Clinical Site

Torrance, California, 90504, United States

RECRUITING

Clinical Site

Hialeah, Florida, 33012, United States

RECRUITING

Clinical Site

Miami, Florida, 33122, United States

RECRUITING

Clinical Site

Miami, Florida, 33135, United States

RECRUITING

Clinical Site

Miami, Florida, 33145, United States

RECRUITING

Clinical Site

Miami Lakes, Florida, 33014, United States

RECRUITING

Clinical Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Clinical Site

Tampa, Florida, 33629, United States

RECRUITING

Clinical Site

West Palm Beach, Florida, 33407, United States

RECRUITING

Clinical Site

Atlanta, Georgia, 30331, United States

RECRUITING

Clinical Site

Stockbridge, Georgia, 30281, United States

RECRUITING

Clinical Site

Chicago, Illinois, 60640, United States

RECRUITING

Clinical Site

Chicago, Illinois, 60641, United States

RECRUITING

Clinical Site

Gaithersburg, Maryland, 20877, United States

RECRUITING

Clinical Site

Glen Oaks, New York, 11004, United States

NOT YET RECRUITING

Clinical Site

Cincinnati, Ohio, 45219, United States

NOT YET RECRUITING

Clinical Site

Richardson, Texas, 75080, United States

RECRUITING

Clinical Site

Burgas, 8000, Bulgaria

RECRUITING

Clinical Site

Kazanlak, 6100, Bulgaria

RECRUITING

Clinical Site

Plovdiv, 4002, Bulgaria

RECRUITING

Clinical Site

Sliven, 8800, Bulgaria

RECRUITING

Clinical Site

Sofia, 1431, Bulgaria

RECRUITING

Clinical Site

Brasov, 507190, Romania

RECRUITING

Clinical Site

Bucharest, 06022, Romania

RECRUITING

Clinical Site

Iași, 700282, Romania

RECRUITING

Clinical Site

Belgrade, 11000, Serbia

RECRUITING

Clinical Site

Kovin, 26220, Serbia

RECRUITING

Clinical Site

Kragujevac, 34000, Serbia

RECRUITING

Clinical Site

Niš, Serbia

RECRUITING

Clinical Site

Novi Kneževac, Serbia

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Central Study Contacts

ITI Clinical Trials

CONTACT

(646) 440-9333ITCIClinicalTrials@itci-inc.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 17, 2024

Study Start

July 17, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

RO(3)US(22)BU(5)SE(5)