Phase 2 N=61 Treatment

A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00088621 ↗

Enrolled (actual)

Serious AEs

20.3%

Results posted

May 2011

Primary outcome: Primary: Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study — 59 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lurasidone 80mg tablet (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Sumitomo Pharma America, Inc.
Primary completion: Oct 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study	59	—

Summary

A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia

Eligibility Criteria

Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either:
Successfully completed
OR
Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00088621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.