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A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01566162
First received: March 27, 2012
Last updated: November 12, 2014
Last verified: November 2014

March 27, 2012
November 12, 2014
April 2012
November 2013   (final data collection date for primary outcome measure)
  • 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.
  • Safety - Treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)
  • Efficacy - PANSS total score and PANSS subscale scores (positive, negative, general psychopathology, and excitability) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    PANSS total score and PANSS subscale scores (positive, negative, general psychopathology, and excitability)
  • Efficacy - Clinical Global Impression-Severity of Illness (CGI-S) score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression-Severity of Illness (CGI-S) score.
Complete list of historical versions of study NCT01566162 on ClinicalTrials.gov Archive Site
  • 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?"
  • Physical examination [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Physical examination
  • Weight, laboratory measures, vital signs, and electrocardiograms (ECGs) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Weight, laboratory measures, vital signs, and electrocardiograms (ECGs)
  • Movement disorders, as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BAS), and Simpson-Angus Scale (SAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Movement disorders, as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BAS), and Simpson-Angus Scale (SAS)
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Columbia-Suicide Severity Rating Scale (C-SSRS)
  • MADRS total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    MADRS total score
  • Short Form-12 Health Survey (SF-12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Short Form-12 Health Survey (SF-12)
  • Modified Specific Levels of Functioning (SLOF) total score and SLOF subscale scores (social functioning and community living skills) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Modified Specific Levels of Functioning (SLOF) total score and SLOF subscale scores (social functioning and community living skills)
  • Brief Adherence Rating Scale (BARS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Brief Adherence Rating Scale (BARS)
  • Smoking questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Smoking questionnaire
  • Intent to Attend assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Intent to Attend assessment
  • Euroqol (EQ-5D) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Euroqol (EQ-5D) Health Outcome measure
  • Health Services Utilization Questionnaire (HSUQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Health Services Utilization Questionnaire (HSUQ)- Health Outcome measure
Not Provided
Not Provided
 
A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
A Twelve Week, Multicenter, Open Label Extension Study in Subjects 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.

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

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: Lurasidone
Lurasidone 40-80 mg taken orally taken once daily
Experimental: Lurasidone
Lurasidone 40 - 80mg flexible dose
Intervention: Drug: Lurasidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
191
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Italy,   Russian Federation,   Serbia,   Slovakia,   South Africa
 
NCT01566162
D1050307, 2011-004790-90
No
Sunovion
Sunovion
Not Provided
Study Director: Lurasidone Medical Director, MD Sunovion
Sunovion
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP