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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513037-20-00

Acronym

ITI-007-452

Enrollment

Registered

2024-11-15

Start date

2024-12-19

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Disorder (Bipolar Mania)

Brief summary

Change from baseline to end of Week 3 in YMRS total score

Detailed description

Change from baseline to end of Week 3 in CGI-S score

Interventions

DRUGThe placebo capsules are identical in appearance to the lumateperone capsules and have the same excipient ingredients as lumateperone but do not have the active compound.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to end of Week 3 in YMRS total score	—

Secondary

Measure	Time frame
Change from baseline to end of Week 3 in CGI-S score	—

Countries

Bulgaria, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026