A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
Status and phase
Completed
Phase 3
Conditions
Schizophrenia
Treatments
Drug: Risperidone
Drug: Placebo
Drug: ITI-007
Details and patient eligibility
About
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.
Enrollment
696 patients
Sex
All
Ages
18 to 60 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
- experiencing an acute exacerbation of psychosis
Exclusion criteria
- 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
696 participants in 4 patient groups, including a placebo group
Lumateperone 14 mg (ITI-007 20 mg Tosylate)
Experimental group
Description:
Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
Treatment:
Drug: ITI-007
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Experimental group
Description:
Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
Treatment:
Drug: ITI-007
Placebo
Placebo Comparator group
Description:
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Treatment:
Drug: Placebo
Risperidone
Active Comparator group
Description:
Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks
Treatment:
Drug: Risperidone
Trial contacts and locations
11
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Data sourced from clinicaltrials.gov
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