At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 676 enrolled
Drug / intervention
Lurasidone +1 moredrug
Likely dose
Lurasidone 80 mgfrom 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 Double-Blind, Placebo-Controlled, Randomized Withdrawal Study Of Lurasidone For The Maintenance Treatment Of Subjects With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Lurasidone and Matching Placebo for Schizophrenia. Completed, enrolled 676 participants across 75 sites in 7 countries.
Detailed Summary
Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that Lurasidone is effective in the long term maintenance treatment of schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesFrance, Italy, Russia, Serbia, Slovakia, South Africa, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedSep 2011
Primary CompletionAug 2013
TodayJul 2026
First PostedSep 19, 2011
Enrollment StartSep 1, 2011
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.8 years ago
Interventions
Lurasidonedrug
Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
Matching Placebodrug
Matching placebo once daily in the evening with a meal or 30 minutes after eating