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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
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Clinical Site
Rogers, Arkansas, United States
Clinical Site
Cerritos, California, United States
Clinical Site
Costa Mesa, California, United States
Clinical Site
Culver City, California, United States
Clinical Site
Garden Grove, California, United States
Clinical Site
Glendale, California, United States
Clinical Site
Lemon Grove, California, United States
Clinical Site
Oceanside, California, United States
Clinical Site
Pico Rivera, California, United States
Clinical Site
Riverside, California, United States
Start Date
March 7, 2016
Primary Completion Date
July 2, 2020
Completion Date
July 2, 2020
Last Updated
May 17, 2023
529
ACTUAL participants
Lumateperone (ITI-007)
DRUG
Placebo
DRUG
Lead Sponsor
Intra-Cellular Therapies, Inc.
NCT04480918
NCT06524505
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07172516