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
Verified date | March 2023 |
Source | Intra-Cellular Therapies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Intra-Cellular Therapies, Inc. |
United States, Bulgaria, Russian Federation, Serbia, Ukraine,
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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