Phase 3
Completed N=500
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Source: ClinicalTrials.gov NCT00549718 ↗Enrolled (actual)
500
Serious AEs
3.2%
Results posted
Dec 2010
Primary outcomePrimary: Change in Total PANSS Score From Baseline to the End of the Double Blind Phase — -19.2; -23.4; -20.5; -17.0 scores on a scale — p=<0.05
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 more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total PANSS Score From Baseline to the End of the Double Blind Phase |
-19.2; -23.4; -20.5; -17.0 | <0.05 sig |
| SECONDARY CGI-S From Baseline to the End of the Double-blind Treatment |
-1.1; -1.4; -1.2; -1.0 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
To be eligible to enter the study, each patient must comply with the following inclusion criteria:
- Provide written informed consent and aged between 18 and 75 years of age.
- Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
- Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
- Able and agrees to remain off prior antipsychotic medication for the duration of study.
- Good physical health on the basis of medical history, physical examination, and laboratory screening.
- Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
Exclusion Criteria
- Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- Any chronic organic disease of the CNS (other than schizophrenia)
- Used investigational compound within 30 days.
- Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Data sourced from ClinicalTrials.gov (NCT00549718). 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.