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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04285515
Other study ID # ITI-007-403
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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