Phase 3 N=292 Randomized Double-blind Treatment

Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia

Chronic Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00789698 ↗

Enrolled (actual)

292

Serious AEs

11.6%

Results posted

Aug 2012

Primary outcome: Primary: Relapse of Psychotic Symptoms — 29; 21 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lurasidone HC1 (Drug); Quetiapine XR (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sumitomo Pharma America, Inc.
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Relapse of Psychotic Symptoms	29; 21	—
SECONDARY Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.	0.22; -0.03	—
SECONDARY Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)	-34.6; -25.7	—
SECONDARY Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores	-1.9; -1.6	—

Summary

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.

Eligibility Criteria

Entry Criteria:

Screening for the present study will take place after subjects' participation in Study D1050233 has been completed, and after providing informed consent.

Inclusion Criteria

Completed all required assessments on the final study visit in Study D1050233.
Suitable for treatment in an outpatient setting.

Exclusion Criteria

Any chronic organic disease of the CNS (other than schizophrenia).
Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00789698). 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.