Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

Major Depressive Disorder 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) or Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285515
• Other study ID #: ITI-007-403
• Status: Completed
• Phase: Phase 3
• Start date: February 27, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2023
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate 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) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• 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
• Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD
• The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1)
• Has at least moderate severity of illness, as measured by a rater-administered MADRS total score = 24 and corresponding to a CGI S score of = 4 at Screening (Visit 1) and Baseline (Visit 2)
• The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis
• Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning
• 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
• The patient has a significant risk for suicidal behavior
• The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Lumateperone
Lumateperone 42mg oral capsule
• Placebos
Placebo oral capsule

Locations

Country	Name	City	State
Bulgaria	Clinical Site	Burgas
Bulgaria	Clinical Site	Kardzhali
Bulgaria	Clinical Site	Plovdiv
Bulgaria	Clinical Site	Ruse
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Varna
Bulgaria	Clinical Site	Veliko Tarnovo
Bulgaria	Clinical Site	Vratsa
Russian Federation	Clinical Site	Ekaterinburg
Russian Federation	Clinical Site	Moscow
Russian Federation	Clinical Site	Saint Petersburg
Russian Federation	Clinical Site	Saint Petersburg
Russian Federation	Clinical Site	Saint Petersburg
Russian Federation	Clinical Site	Saint Petersburg
Russian Federation	Clinical Site	Saint Petersburg
Russian Federation	Clinical Site	Tomsk
Serbia	Clinical Site	Belgrade
Serbia	Clinical Site	Kovin
Serbia	Clinical Site	Kragujevac
Ukraine	Clinical Site	Kyiv
Ukraine	Clinical Site	Lviv
Ukraine	Clinical site	Odesa
Ukraine	Clinical Site	Odesa
Ukraine	Clinical Site	Poltava
Ukraine	Clinical Site	Smila
Ukraine	Clinical Site	Vinnytsia
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Bellevue	Washington
United States	Clinical Site	Cedarhurst	New York
United States	Clinical Site	Charlotte	North Carolina
United States	Clinical Site	Decatur	Georgia
United States	Clinical Site	Garden Grove	California
United States	Clinical Site	Lauderhill	Florida
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	Sherman Oaks	California

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	Montgomery-Åsberg Depression Rating Scale		Day 43
Secondary	Clinical Global Impression Scale - Severity		Day 43