Clinical trial NCT03249376: Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) Conducted Globally
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 381
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 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: 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
* able to provide written informed consent

Major Exclusion Criteria:

* any female subject who is pregnant or breast-feeding
* 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 (CGI-BP-S) Total Score
timeFrame: Baseline to Day 43
measure: Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score
timeFrame: Baseline to Day 43
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Site
state: Alabama
city: Sherman Oaks
country: United States
facility: Clinical Site
state: California
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Orange City
country: United States
facility: Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Site
state: Georgia
city: Decatur
country: United States
facility: Clinical Site
state: Georgia
city: Chicago
country: United States
facility: Clinical Site
state: Illinois
city: Joliet
country: United States
facility: Clinical Site
state: Illinois
city: Shreveport
country: United States
facility: Clinical Site
state: Louisiana
city: Saint Louis
country: United States
facility: Clinical Site
state: Missouri
city: Buffalo
country: United States
facility: Clinical Site
state: New York
city: Charlotte
country: United States
facility: Clinical Site
state: North Carolina
city: The Woodlands
country: United States
facility: Clinical Site
state: Texas
city: Bothell
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: Plovdiv
country: Bulgaria
facility: Clinical Site
city: Ruse
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Targovishte
country: Bulgaria
facility: Clinical Site
city: Tsarev Brod
country: Bulgaria
facility: Clinical Site
city: Varna
country: Bulgaria
facility: Clinical Site
city: Veliko Tarnovo
country: Bulgaria
facility: Clinical Site
city: Barranquilla
country: Colombia
facility: Clinical Site
city: Bello
country: Colombia
facility: Clinical Site
city: Pereira
country: Colombia
facility: Clinical Site
city: Ekaterinburg
country: Russian Federation
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: Kragujevac
country: Serbia
facility: Clinical Site
city: Novi Sad
country: Serbia
facility: Clinical Site
city: Ivano-Frankivs'k
country: Ukraine
facility: Clinical Site
city: Kharkiv
country: Ukraine
facility: Clinical Site
city: Kherson
country: Ukraine
facility: Clinical Site
city: Lviv
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: Uzhgorod
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:
citation: Calabrese JR, Durgam S, Satlin A, Vanover KE, Davis RE, Chen R, Kozauer SG, Mates S, Sachs GS. Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. Am J Psychiatry. 2021 Dec;178(12):1098-1106. doi: 10.1176/appi.ajp.2021.20091339. Epub 2021 Sep 23.