Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

Intra-Cellular Therapies

Status and phase: Completed; Phase 3

Conditions: Bipolar Depression

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02600507

ITI-007-402

Details and patient eligibility

About

The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate 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: 529 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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
• treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms

Exclusion criteria

• any subject unable to provide informed consent
• any female subject who is pregnant or breastfeeding
• 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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529 participants in 3 patient groups, including a placebo group

Lumateperone 28 mg (ITI-007 40 mg tosylate)

Experimental group

Description:

Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks

Treatment:

Drug: Lumateperone (ITI-007)

Lumateperone 42 mg (ITI-007 60 mg tosylate)

Experimental group

Description:

Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks

Treatment:

Drug: Lumateperone (ITI-007)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo