A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia|
- Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
- Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score [ Time Frame: Baseline to week 12 LOCF endpoint ] [ Designated as safety issue: No ]The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
- Short Form-12 Health Survey (SF-12) [ Time Frame: Baseline to week 12 LOCF endpoint ] [ Designated as safety issue: No ]The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
- Modified Specific Levels of Functioning (SLOF) Total Score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.
- Brief Adherence Rating Scale (BARS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.
- Smoking Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).
- Intent to Attend Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = "Not at all" and 9 = "Extremely". The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: "How likely is it that you will complete the study?"
|Study Start Date:||April 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Lurasidone 40 - 80mg flexible dose
Lurasidone 40-80 mg taken orally taken once daily
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566162
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|Study Director:||Lurasidone Medical Director, MD||Sunovion|