A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
A Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 After 6 Weeks of Treatment in Patients With Schizophrenia
1 other identifier
interventional
696
1 country
11
Brief Summary
The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Jun 2015
Shorter than P25 for phase_3 schizophrenia
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
October 2, 2025
CompletedOctober 2, 2025
September 1, 2025
1.2 years
June 9, 2015
March 27, 2025
September 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms.
6 weeks
Secondary Outcomes (1)
Change From Baseline to Week 6 in Clinical Global Impressions-Severity of Illness Scale
6 weeks
Study Arms (4)
Lumateperone 14 mg (ITI-007 20 mg Tosylate)
EXPERIMENTALLumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
EXPERIMENTALLumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
Placebo
PLACEBO COMPARATORPlacebo administered orally as visually-matched capsules once daily for 6 weeks
Risperidone
ACTIVE COMPARATORRisperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
- experiencing an acute exacerbation of psychosis
You may not qualify if:
- any subject unable to provide informed consent
- any female subject who is pregnant or breast-feeding
- any subject judged to be medically inappropriate for study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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
Related Publications (1)
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.
PMID: 36883881DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- ITI Clinical Trials
- Organization
- Intra-Cellular Therapies, Inc.
Study Officials
- STUDY DIRECTOR
Kimberly Vanover, Ph.D.
Intra-Cellular Therapies, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 11, 2015
Study Start
June 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
October 2, 2025
Results First Posted
October 2, 2025
Record last verified: 2025-09