CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 244 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/NCT01143077
NCT01143077Phase 3Completed
CompareCT.gov

A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents

Sumitomo Pharma America, Inc.·interventional·Posted Jun 14, 2010·Updated Apr 17, 2013

In Brief

A Phase 3 clinical trial evaluating Lurasidone HCl for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 244 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 current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2010
Enrollment StartJun 1, 2010
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.1 years ago

Interventions

Lurasidone HCldrug

Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks