CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 149 enrolled
Drug / intervention
Lurasidone HCldrug
Likely dose
Lurasidone HCl 40 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.

Search/NCT01143090
NCT01143090Phase 3Completed
CompareCT.gov

A 24-Week, Flexible-Dose, Open-label Extension Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Protocol No. D1050290)

Sumitomo Pharma America, Inc.·interventional·Posted Jun 14, 2010·Updated Jun 12, 2015

In Brief

A Phase 3 clinical trial evaluating Lurasidone HCl for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 149 participants across 27 sites.

Detailed Summary

Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2010
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.1 years ago

Interventions

Lurasidone HCldrug

40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months