Clinical trial NCT02600494: Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Site
state: Arkansas
city: Rogers
country: United States
facility: Clinical Site
state: Arkansas
city: Cerritos
country: United States
facility: Clinical Site
state: California
city: Culver City
country: United States
facility: Clinical Site
state: California
city: Garden Grove
country: United States
facility: Clinical Site
state: California
city: Lemon Grove
country: United States
facility: Clinical Site
state: California
city: National City
country: United States
facility: Clinical Site
state: California
city: Oakland
country: United States
facility: Clinical Site
state: California
city: Oceanside
country: United States
facility: Clinical Site
state: California
city: Orange
country: United States
facility: Clinical Site
state: California
city: Pico Rivera
country: United States
facility: Clinical Site
state: California
city: Riverside
country: United States
facility: Clinical Site
state: California
city: San Diego
country: United States
facility: Clinical Site
state: California
city: San Marcos
country: United States
facility: Clinical Site
state: California
city: Santa Rosa
country: United States
facility: Clinical Site
state: California
city: Colorado Springs
country: United States
facility: Clinical Site
state: Colorado
city: Bradenton
country: United States
facility: Clinical Site
state: Florida
city: Fort Myers
country: United States
facility: Clinical Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Site
state: Florida
city: Lauderhill
country: United States
facility: Clinical Site
state: Florida
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: North Miami
country: United States
facility: Clinical Site
state: Florida
city: Orlando
country: United States
facility: Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Site
state: Georgia
city: Chicago
country: United States
facility: Clinical Site
state: Illinois
city: Hoffman Estates
country: United States
facility: Clinical Site
state: Illinois
city: Lake Charles
country: United States
facility: Clinical Site
state: Louisiana
city: Baltimore
country: United States
facility: Clinical Site
state: Maryland
city: Boston
country: United States
facility: Clinical Site
state: Massachusetts
city: O'Fallon
country: United States
facility: Clinical Site
state: Missouri
city: Saint Louis
country: United States
facility: Clinical Site
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Site
state: Nevada
city: Berlin
country: United States
facility: Clinical Site
state: New Jersey
city: Cherry Hill
country: United States
facility: Clinical Site
state: New Jersey
city: Marlton
country: United States
facility: Clinical Site
state: New Jersey
city: Toms River
country: United States
facility: Clinical Site
state: New Jersey
city: Brooklyn
country: United States
facility: Clinical Site
state: New York
city: Cedarhurst
country: United States
facility: Clinical Site
state: New York
city: New York
country: United States
facility: Clinical Site
state: New York
city: Rochester
country: United States
facility: Clinical Site
state: New York
city: Staten Island
country: United States
facility: Clinical Site
state: New York
city: Cincinnati
country: United States
facility: Clinical Site
state: Ohio
city: Cleveland
country: United States
facility: Clinical Site
state: Ohio
city: Dayton
country: United States
facility: Clinical Site
state: Ohio
city: Garfield Heights
country: United States
facility: Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Clinical Site
state: Oklahoma
city: Allentown
country: United States
facility: Clinical Site
state: Pennsylvania
city: Norristown
country: United States
facility: Clinical Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Site
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Site
state: Tennessee
city: Austin
country: United States
facility: Clinical Site
state: Texas
city: Dallas
country: United States
facility: Clinical Site
state: Texas
city: Houston
country: United States
facility: Clinical Site
state: Texas
city: Petersburg
country: United States
facility: Clinical Site
state: Virginia
city: Everett
country: United States
facility: Clinical Site
state: Washington
Study officials:
affiliation: Intra-Cellular Therapies, Inc. (ITI)
name: Susan Kozauer, MD
role: STUDY_DIRECTOR
References: