Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249376
• Other study ID #: ITI-007-404
• Status: Completed
• Phase: Phase 3
• Start date: November 27, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2022
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Lumateperone
Lumateperone 42 mg (ITI-007 60 mg tosylate)

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Bulgaria	Clinical Site	Burgas
Bulgaria	Clinical Site	Kardzhali
Bulgaria	Clinical Site	Lovech
Bulgaria	Clinical Site	Plovdiv
Bulgaria	Clinical Site	Ruse
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Targovishte
Bulgaria	Clinical Site	Tsarev Brod
Bulgaria	Clinical Site	Varna
Bulgaria	Clinical Site	Veliko Tarnovo
Colombia	Clinical Site	Barranquilla
Colombia	Clinical Site	Bello
Colombia	Clinical Site	Pereira
Russian Federation	Clinical Site	Ekaterinburg
Russian Federation	Clinical Site	Moscow
Russian Federation	Clinical Site	Nizhny Novgorod
Russian Federation	Clinical Site	Omsk
Russian Federation	Clinical Site	Saint Petersburg
Russian Federation	Clinical Site	Samara
Russian Federation	Clinical Site	Saratov
Russian Federation	Clinical Site	Tomsk
Serbia	Clinical Site	Belgrade
Serbia	Clinical Site	Kragujevac
Serbia	Clinical Site	Novi Sad
Ukraine	Clinical Site	Ivano-Frankivs'k
Ukraine	Clinical Site	Kharkiv
Ukraine	Clinical Site	Kherson
Ukraine	Clinical Site	Lviv
Ukraine	Clinical Site	Odesa
Ukraine	Clinical Site	Poltava
Ukraine	Clinical Site	Smila
Ukraine	Clinical Site	Uzhgorod
Ukraine	Clinical Site	Vinnytsia
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Birmingham	Alabama
United States	Clinical Site	Bothell	Washington
United States	Clinical Site	Buffalo	New York
United States	Clinical Site	Charlotte	North Carolina
United States	Clinical Site	Chicago	Illinois
United States	Clinical Site	Decatur	Georgia
United States	Clinical Site	Joliet	Illinois
United States	Clinical Site	Miami	Florida
United States	Clinical Site	Orange City	Florida
United States	Clinical Site	Saint Louis	Missouri
United States	Clinical Site	Sherman Oaks	California
United States	Clinical Site	Shreveport	Louisiana
United States	Clinical Site	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Colombia,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.	Baseline to Day 43
Secondary	Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score	The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score.	Baseline to Day 43
Secondary	Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score	The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good.	Baseline to Day 43