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Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

NCT03249376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2022-06-03

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Lumateperone

Lumateperone 42 mg (ITI-007 60 mg tosylate)

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Kozauer, MD · Intra-Cellular Therapies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2019-03-01
Completion
2019-03-01
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Colombia
  • Russia
  • Serbia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03249376 on ClinicalTrials.gov