Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600507
• Other study ID #: ITI-007-402
• Status: Completed
• Phase: Phase 3
• Start date: March 7, 2016
• Est. completion date: July 2, 2020

Study information

• Verified date: April 2021
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: July 2, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Lumateperone (ITI-007)

• Placebo

Locations

Country	Name	City	State
Bulgaria	Clinical Site	Burgas
Bulgaria	Clinical Site	Kardzhali
Bulgaria	Clinical Site	Lovech
Bulgaria	Clinical Site	Pleven
Bulgaria	Clinical Site	Plovdiv
Bulgaria	Clinical Site	Ruse
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Varna
Bulgaria	Clinical Site	Veliko Tarnovo
Bulgaria	Clinical Site	Vratsa
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	Kovin
Serbia	Clinical Site	Novi Sad
Serbia	Clinical Site	Sumadija
Ukraine	Clinical Site	Ivano-Frankivs'k
Ukraine	Clinical Site	Kharkiv
Ukraine	Clinical Site	Kropyvnytskyi
Ukraine	Clinical Site	Odesa
Ukraine	Clinical Site	Poltava
Ukraine	Clinical Site	Smila
Ukraine	Clinical Site	Vasylkiv
Ukraine	Clinical Site	Vinnytsia
United States	Clinical Site	Allentown	Pennsylvania
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Baltimore	Maryland
United States	Clinical Site	Berlin	New Jersey
United States	Clinical Site	Cedarhurst	New York
United States	Clinical Site	Cerritos	California
United States	Clinical Site	Charlotte	North Carolina
United States	Clinical Site	Cherry Hill	New Jersey
United States	Clinical Site	Chicago	Illinois
United States	Clinical Site	Cincinnati	Ohio
United States	Clinical Site	Costa Mesa	California
United States	Clinical Site	Culver City	California
United States	Clinical Site	Dayton	Ohio
United States	Clinical Site	Everett	Washington
United States	Clinical Site	Garden Grove	California
United States	Clinical Site	Garfield Heights	Ohio
United States	Clinical Site	Glendale	California
United States	Clinical Site	Jacksonville	Florida
United States	Clinical Site	Lake Charles	Louisiana
United States	Clinical Site	Las Vegas	Nevada
United States	Clinical Site	Lauderhill	Florida
United States	Clinical Site	Lemon Grove	California
United States	Clinical Site	Miami	Florida
United States	Clinical Site	New York	New York
United States	Clinical Site	O'Fallon	Missouri
United States	Clinical Site	Oceanside	California
United States	Clinical Site	Orange City	Florida
United States	Clinical Site	Orlando	Florida
United States	Clinical Site	Philadelphia	Pennsylvania
United States	Clinical Site	Pico Rivera	California
United States	Clinical Site	Riverside	California
United States	Clinical Site	Rochester	New York
United States	Clinical Site	Rogers	Arkansas
United States	Clinical Site	Saint Louis	Missouri
United States	Clinical Site	San Diego	California
United States	Clinical Site	Santa Rosa	California
United States	Clinical Site	Savannah	Georgia
United States	Clinical Site	Sherman Oaks	California
United States	Clinical Site	Staten Island	New York
United States	Clinical Site	Temecula	California
United States	Clinical Site	The Woodlands	Texas
United States	Clinical Site	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  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-Severity (CGI-BP-S) Depression Score	The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill).	Baseline to Day 43