Phase 2
N=334
Study of a Novel Antipsychotic ITI-007 in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01499563 ↗Enrolled (actual)
334
Serious AEs
0.6%
Results posted
Oct 2025
Primary outcome: Primary: Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score — -13.2; -8.3; -7.4; -13.4 score on a scale — p=0.017
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ITI-007 (Drug); Placebo (Drug); Risperidone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intra-Cellular Therapies, Inc.
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-13.2; -8.3; -7.4; -13.4 | 0.017 sig |
| SECONDARY Change From Baseline to Day 8 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-4.0; -4.7; -2.6; -6.3 | — |
| SECONDARY Change From Baseline to Day 15 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-7.8; -4.2; -4.5; -9.6 | — |
| SECONDARY Change From Baseline to Day 22 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-10.5; -6.6; -4.6; -10.8 | — |
Summary
The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.
Eligibility Criteria
Inclusion Criteria
- Patient's age is 18-55
- Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis
- Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years
Exclusion Criteria
- Any female patient who is pregnant or breast-feeding
- Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma
- Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features
- Any patient considered to be an imminent danger to themselves or others
- Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol
- Any patient judged by the Investigator to be inappropriate for the study
Data sourced from ClinicalTrials.gov (NCT01499563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.