CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 180 enrolled
Drug / intervention
Lurasidone +1 moredrug
Likely dose
Lurasidone 80 mg orally once daily (AM dosing)AI-extracted
Key inclusion· 2
  • ✓Diagnosed with schizophrenia per DSM-IV criteria confirmed by SCID-CV interview
  • ✓Must agree to voluntary hospitalization for at least 31 days at treatment start
Key exclusion· 2
  • ✕Use of investigational drug within the past 30 days
  • ✕Prior participation in a study of lurasidone

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00088634
NCT00088634Phase 2Completed
CompareCT.gov

A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia

Sumitomo Pharma America, Inc.·interventional·Posted Aug 2, 2004·Updated Apr 8, 2016

In Brief

A Phase 2 clinical trial evaluating Lurasidone and Placebo for Schizophrenia. Completed, enrolled 180 participants across 22 sites.

Detailed Summary

A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2, 2004
Enrollment StartMay 1, 2004
Primary CompletionDec 1, 2004
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 21.9 years ago

Interventions

Lurasidonedrug

80 mg AM dosing once daily

Placebodrug

Matching Placebo to 40mg lurasidone tablets