Phase 3
Completed N=460
Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT00711269 ↗Enrolled (actual)
460
Serious AEs
5.9%
Results posted
Oct 2018
Primary outcomePrimary: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF) — -6.1; -4.3; -2.5; -7.1 units on a scale — p=0.149
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF) |
-6.1; -4.3; -2.5; -7.1 | 0.149 |
| SECONDARY Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF) |
-2.0; -1.4; -0.6; -2.9 | 0.069 |
| SECONDARY Change From Baseline in the PANSS Negative Subscales at Week 6 |
-1.6; -1.7; -0.9; -1.7 | 0.289 |
| SECONDARY Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF) |
-2.4; -1.2; -1.0; -2.6 | 0.251 |
| SECONDARY Proportion of Participants With Treatment-emergent Adverse Events (TEAEs) |
105; 103; 101; 53 | — |
| SECONDARY Proportion of Participants With TEAEs Leading to Discontinuation |
18; 18; 27; 7 | — |
| SECONDARY Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) |
8; 7; 10; 2 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Patient meets DSM-IV criteria for schizophrenia.
- Patient is 18 or older but younger than 75 years of age on the day of signing informed consent.
- Patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent.
Main Exclusion Criteria:
- Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
- Patient has Parkinson's disease.
- Patient has a history or complication of malignancy.
Data sourced from ClinicalTrials.gov (NCT00711269). 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.