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: April 2, 2014
Last verified: April 2014

March 27, 2012
April 2, 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 ]
    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.
Same as current
Complete list of historical versions of study NCT01566162 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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
April 2014

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