Phase 3
Completed N=191
A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01566162 ↗Enrolled (actual)
191
Serious AEs
6.8%
Results posted
Nov 2014
Primary outcomePrimary: Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs) — 72; 7; 13 participants
Summary
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs) |
72; 7; 13 | — |
| PRIMARY Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score |
-8.4 | — |
| PRIMARY Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score. |
-0.48 | — |
| SECONDARY Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score |
-3.3 | — |
| SECONDARY Short Form-12 Health Survey (SF-12) |
-0.45 | — |
| SECONDARY Modified Specific Levels of Functioning (SLOF) Total Score. |
-1.8 | — |
| SECONDARY Brief Adherence Rating Scale (BARS) |
99.0 | — |
| SECONDARY Smoking Questionnaire |
11.1 | — |
| SECONDARY Intent to Attend Assessment |
8.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has agreed to participate by providing written informed consent.
- Subject will be eligible to participate if one of the following criteria is met:
- Subject has completed the 28-week double-blind phase of study D1050238
- Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238
- Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.
- Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238.
- Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
Exclusion Criteria
- Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
- Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.
Data sourced from ClinicalTrials.gov (NCT01566162). 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.