Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

Intra-Cellular Therapies

Status and phase: Completed; Phase 3

Conditions: Bipolar Depression

Treatments: Drug: Placebo; Drug: ITI-007 (Lumateperone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02600494

ITI-007-401

Details and patient eligibility

About

The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.

Enrollment: 554 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

Major Exclusion Criteria:

• any subject unable to provide informed consent
• 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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554 participants in 3 patient groups, including a placebo group

40 mg ITI-007 (Lumateperone)

Experimental group

Description:

40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks

Treatment:

Drug: ITI-007 (Lumateperone)

60 mg ITI-007 (Lumateperone)

Experimental group

Description:

60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks

Treatment:

Drug: ITI-007 (Lumateperone)

Placebo

Placebo Comparator group

Description:

Placebo administered orally as visually-matched capsules once daily for 6 weeks

Treatment:

Drug: Placebo