Clinical trial NCT02600507: Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate 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 Adjunctive to Lithium or Valproate 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: 529
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline to Day 43
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score
timeFrame: Baseline to Day 43
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Clinical Site
state: Arkansas
city: Cerritos
country: United States
facility: Clinical Site
state: California
city: Costa Mesa
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: Glendale
country: United States
facility: Clinical Site
state: California
city: Lemon Grove
country: United States
facility: Clinical Site
state: California
city: Oceanside
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: Santa Rosa
country: United States
facility: Clinical Site
state: California
city: Sherman Oaks
country: United States
facility: Clinical Site
state: California
city: Temecula
country: United States
facility: Clinical Site
state: California
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: Orange City
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: Savannah
country: United States
facility: Clinical Site
state: Georgia
city: Chicago
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: 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: Toms River
country: United States
facility: Clinical Site
state: New Jersey
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: Charlotte
country: United States
facility: Clinical Site
state: North Carolina
city: Cincinnati
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: Allentown
country: United States
facility: Clinical Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Site
state: Pennsylvania
city: The Woodlands
country: United States
facility: Clinical Site
state: Texas
city: Everett
country: United States
facility: Clinical Site
state: Washington
city: Burgas
country: Bulgaria
facility: Clinical Site
city: Kardzhali
country: Bulgaria
facility: Clinical Site
city: Lovech
country: Bulgaria
facility: Clinical Site
city: Pleven
country: Bulgaria
facility: Clinical Site
city: Plovdiv
country: Bulgaria
facility: Clinical Site
city: Ruse
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Varna
country: Bulgaria
facility: Clinical Site
city: Veliko Tarnovo
country: Bulgaria
facility: Clinical Site
city: Vratsa
country: Bulgaria
facility: Clinical Site
city: Moscow
country: Russian Federation
facility: Clinical Site
city: Nizhny Novgorod
country: Russian Federation
facility: Clinical Site
city: Omsk
country: Russian Federation
facility: Clinical Site
city: Saint Petersburg
country: Russian Federation
facility: Clinical Site
city: Samara
country: Russian Federation
facility: Clinical Site
city: Saratov
country: Russian Federation
facility: Clinical Site
city: Tomsk
country: Russian Federation
facility: Clinical Site
city: Belgrade
country: Serbia
facility: Clinical Site
city: Kovin
country: Serbia
facility: Clinical Site
city: Novi Sad
country: Serbia
facility: Clinical Site
city: Sumadija
country: Serbia
facility: Clinical Site
city: Ivano-Frankivs'k
country: Ukraine
facility: Clinical Site
city: Kharkiv
country: Ukraine
facility: Clinical Site
city: Kropyvnytskyi
country: Ukraine
facility: Clinical Site
city: Odesa
country: Ukraine
facility: Clinical Site
city: Poltava
country: Ukraine
facility: Clinical Site
city: Smila
country: Ukraine
facility: Clinical Site
city: Vasylkiv
country: Ukraine
facility: Clinical Site
city: Vinnytsia
country: Ukraine
facility: Clinical Site
Study officials:
affiliation: Intra-Cellular Therapies, Inc.
name: Susan Kozauer, MD
role: STUDY_DIRECTOR
References: