CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 356 enrolled
Drug / intervention
Lurasidone 20 mg +4 moredrug
Likely dose
Lurasidone 20 mg, 40 mg, or 80 mg once daily; Haloperidol 10 mg once dailyAI-extracted
Key inclusion· 5
  • ✓Primary diagnosis of schizophrenia
  • ✓Hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
  • ✓Duration of illness at least one year
  • ✓BPRS score ≥42 at baseline and PANSS positive symptom subscore ≥4 in at least two items
Key exclusion· 5
  • ✕Psychiatric hospitalizations other than current hospitalization within 1 month prior to screening
  • ✕Treatment-resistant schizophrenia
  • ✕Substance abuse
  • ✕Prolactin level >200 ng/mL at baseline

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

Search/NCT00044044
NCT00044044Phase 2Completed
CompareCT.gov

A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms

Sumitomo Pharma America, Inc.·interventional·Posted Aug 20, 2002·Updated Apr 17, 2014

In Brief

A Phase 2 clinical trial evaluating Lurasidone 20 mg, Lurasidone 40mg, and 3 other interventions for Schizophrenia. Completed, enrolled 356 participants across 34 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.

Study Details

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

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 20, 2002
Enrollment StartJul 1, 2002
Primary CompletionMay 1, 2003
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 23.9 years ago

Interventions

Lurasidone 20 mgdrug

Lurasidone 20mg/day tablets

Lurasidone 40mgdrug

Lurasidone 40mg/day tablets

Lurasidone 80 mgdrug

Lurasidone 80mg/day - 2 40mg tablets

Haloperidol 10mgdrug

Haloperidol 10mg/day tablets

Placebodrug

Matching Placebo to Lurasdione and Haloperidol