A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia
Overview
- Phase
- Phase 3
- Intervention
- Lurasidone
- Conditions
- Schizophrenia
- Sponsor
- Sumitomo Pharma America, Inc.
- Enrollment
- 191
- Locations
- 62
- Primary Endpoint
- Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed Description
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 who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study
Investigators
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 D
- •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.
Arms & Interventions
Lurasidone
Lurasidone 40 - 80mg flexible dose
Intervention: Lurasidone
Outcomes
Primary Outcomes
Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)
Time Frame: 12 weeks
Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)
Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Baseline to week 12 LOCF endpoint
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.
Time Frame: Baseline to week 12 LOCF endpoint
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Secondary Outcomes
- Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score(Baseline to week 12 LOCF endpoint)
- Short Form-12 Health Survey (SF-12)(Baseline to week 12 LOCF endpoint)
- Modified Specific Levels of Functioning (SLOF) Total Score.(12 weeks)
- Brief Adherence Rating Scale (BARS)(12 weeks)
- Smoking Questionnaire(12 weeks)
- Intent to Attend Assessment(12 weeks)