A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
NCT ID: NCT02469155
Last Updated: 2025-10-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
696 participants
INTERVENTIONAL
2015-06-30
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of a Novel Antipsychotic ITI-007 in Schizophrenia
NCT01499563
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
NCT02109562
A Study of the Effectiveness and Safety of Long-acting Injectable Risperidone Versus Placebo in the Treatment of Patients With Schizophrenia
NCT00253136
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia
NCT00460512
An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia
NCT01175135
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lumateperone 14 mg (ITI-007 20 mg Tosylate)
Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
ITI-007
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
ITI-007
Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
Risperidone
Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks
Risperidone
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ITI-007
Risperidone
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* experiencing an acute exacerbation of psychosis
Exclusion Criteria
* any female subject who is pregnant or breast-feeding
* any subject judged to be medically inappropriate for study participation
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kimberly Vanover, Ph.D.
Role: STUDY_DIRECTOR
Intra-Cellular Therapies, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Site
Little Rock, Arkansas, United States
Clinical Site
Springdale, Arkansas, United States
Clinical Site
Culver City, California, United States
Clinical Site
Lemon Grove, California, United States
Clinical Site
Long Beach, California, United States
Clinical Site
San Diego, California, United States
Clinical Site
North Miami, Florida, United States
Clinical Site
Berlin, New Jersey, United States
Clinical Site
Marlton, New Jersey, United States
Clinical Site
Austin, Texas, United States
Clinical Site
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Citrome L, Durgam S, Edwards JB, Davis RE. Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Mar 6;84(2):22r14631. doi: 10.4088/JCP.22r14631.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ITI-007-302
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.