Phase 3
Completed N=388
A Clinical Trial of Lurasidone in Treatment of Schizophrenia
Source: ClinicalTrials.gov NCT02002832 ↗Enrolled (actual)
388
Serious AEs
0.3%
Results posted
Apr 2019
Primary outcomePrimary: Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores. — -31.2; -34.9 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose, non-inferiority and multicentre study designed to evaluate the efficacy and safety of lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores. |
-31.2; -34.9 | — |
| SECONDARY Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6. |
2.0; 1.9 | — |
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent and aged between 18 and 65 years of age.
- Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline.
- Not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study.
- Able and agrees to remain off prior antipsychotic medication for the duration of study.
- 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)
- Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form.
- Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Data sourced from ClinicalTrials.gov (NCT02002832). 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.