CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 101 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.

Search/NCT01569659
NCT01569659Phase 4Completed
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High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia

Northwestern University·interventional·Posted Apr 3, 2012·Updated Feb 28, 2025

In Brief

A Phase 4 clinical trial evaluating Lurasidone for Schizophrenia. Completed, enrolled 101 participants across 2 sites.

Detailed Summary

The aim of this study is to compare the efficacy of a flexible high dose of lurasidone to a standard dose of lurasidone in patients with treatment resistant schizophrenia or schizoaffective disorder. Efficacy of both dosage groups will be measured through testing of positive symptoms and other components of psychopathology (negative symptoms, general psychopathology, anxiety, depression, cognitive function, global function, severity of illness and tolerability). Patients must qualify for treatment resistance after two or more antipsychotic drug trials to be included in this trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsSumitomo Pharma America, Inc.

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 3, 2012
Enrollment StartOct 1, 2011
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.2 years ago

Interventions

Lurasidonedrug

80 mg/day for up to 30 weeks

Lurasidonedrug

Up to 240 mg/day for up to 30 weeks