At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 450 enrolled
Drug / intervention
ITI-007 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating ITI-007 and Placebo for Schizophrenia. Completed, enrolled 450 participants across 11 sites.
Detailed Summary
The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedNov 2014
Primary CompletionJul 2015
Study CompletionSep 2015
TodayJul 2026
First PostedNov 4, 2014
Enrollment StartNov 1, 2014
Primary CompletionJul 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.7 years ago
Interventions
ITI-007drug
Placebodrug