Phase 3
Completed N=292
Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia
Source: ClinicalTrials.gov NCT00789698 ↗Enrolled (actual)
292
Serious AEs
11.6%
Results posted
Aug 2012
Primary outcomePrimary: Relapse of Psychotic Symptoms — 29; 21 participants
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.
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 | — |
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.
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. Informational only — not medical advice.