Phase 3
Completed N=457
A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01614899 ↗Enrolled (actual)
457
Serious AEs
2.2%
Results posted
Oct 2018
Primary outcomePrimary: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 — -17.9; -17.3; -13.1 units on a scale — p=0.050
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 |
-17.9; -17.3; -13.1 | 0.050 |
| SECONDARY Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 6 |
-0.86; -0.97; -0.79 | 0.594 |
| SECONDARY Change From Baseline in PANSS Positive Subscale Scores at Week 6 |
-5.4; -6.2; -4.2 | 0.143 |
| SECONDARY Change From Baseline in PANSS Negative Subscale Scores at Week 6 |
-3.9; -3.4; -2.9 | 0.116 |
| SECONDARY Change From Baseline in PANSS General Psychopathology Subscale Scores at Week 6 |
-8.8; -7.9; -6.3 | 0.036 sig |
| SECONDARY Proportion of Participants With Treatment-emergent Adverse Events (TEAEs) |
103; 107; 97 | — |
| SECONDARY Proportion of Participants With TEAEs Leading to Discontinuation |
11; 11; 16 | — |
| SECONDARY Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) |
4; 3; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Patient meets DSM-IV-TR criteria for schizophrenia.
- Patient is aged 18 through 74 years at informed consent.
- Patient understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study
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 (NCT01614899). 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.