Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

Intra-Cellular Therapies

Status and phase: Completed; Phase 3

Conditions: Bipolar Depression

Treatments: Drug: Lumateperone; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03249376

ITI-007-404

Details and patient eligibility

About

The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.

Enrollment: 381 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

• male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
• experiencing a current major depressive episode
• able to provide written informed consent

Major Exclusion Criteria:

• any female subject who is pregnant or breast-feeding
• any subject judged to be medically inappropriate for study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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381 participants in 2 patient groups, including a placebo group

Lumateperone

Experimental group

Description:

Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks

Treatment:

Drug: Lumateperone

Placebo

Placebo Comparator group

Description:

Placebo administered once daily every evening for 6 weeks

Treatment:

Other: Placebo