Clinical trial NCT04285515: Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Major Depressive Disorder
Keywords: Mixed Features
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-26
Enrollment: 488
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Day 43
Secondary outcomes:
measure: Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)
timeFrame: Day 43
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Clinical Site
state: California
city: Oceanside
country: United States
facility: Clinical Site
state: California
city: Sherman Oaks
country: United States
facility: Clinical Site
state: California
city: Lauderhill
country: United States
facility: Clinical Site
state: Florida
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: O'Fallon
country: United States
facility: Clinical Site
state: Missouri
city: Cedarhurst
country: United States
facility: Clinical Site
state: New York
city: New York
country: United States
facility: Clinical Site
state: New York
city: Charlotte
country: United States
facility: Clinical Site
state: North Carolina
city: Bellevue
country: United States
facility: Clinical Site
state: Washington
city: Burgas
country: Bulgaria
facility: Clinical Site
city: Kardzhali
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: Sofia
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Varna
country: Bulgaria
facility: Clinical Site
city: Veliko Tarnovo
country: Bulgaria
facility: Clinical Site
city: Vratsa
country: Bulgaria
facility: Clinical Site
city: Ekaterinburg
country: Russian Federation
facility: Clinical Site
city: Moscow
country: Russian Federation
facility: Clinical Site
city: Saint Petersburg
country: Russian Federation
facility: Clinical Site
city: Saint Petersburg
country: Russian Federation
facility: Clinical Site
city: Saint Petersburg
country: Russian Federation
facility: Clinical Site
city: Saint Petersburg
country: Russian Federation
facility: Clinical Site
city: Saint Petersburg
country: Russian Federation
facility: Clinical Site
city: Tomsk
country: Russian Federation
facility: Clinical Site
city: Belgrade
country: Serbia
facility: Clinical Site
city: Kovin
country: Serbia
facility: Clinical Site
city: Kragujevac
country: Serbia
facility: Clinical Site
city: Kyiv
country: Ukraine
facility: Clinical Site
city: Lviv
country: Ukraine
facility: Clinical Site
city: Odesa
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: Vinnytsia
country: Ukraine
facility: Clinical Site
Study officials:
affiliation: Intra-Cellular Therapies, Inc.
name: Susan Kozauer, MD
role: STUDY_DIRECTOR
References: