Phase 3
Completed N=162
Lurasidone Extended Use Study
Source: ClinicalTrials.gov NCT01485640 ↗Enrolled (actual)
162
Serious AEs
4.3%
Results posted
Mar 2015
Primary outcomePrimary: Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs — 63; 7; 10 participants
Summary
This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs |
63; 7; 10 | — |
| SECONDARY Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S |
-0.18 | — |
Eligibility Criteria
Inclusion Criteria
- The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required.
- The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
- The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
- The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone
Exclusion Criteria
- The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior.
- The subject resides in a country where lurasidone has been approved for any indication.
- The subject is currently enrolled in any other investigational study.
- The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
Data sourced from ClinicalTrials.gov (NCT01485640). 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.