A Twelve Week, Open Label Extension Study in Patients With Schizophrenia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Lurasidone	Phase 3

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Lurasidone

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	250
Study Start Date:	April 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lurasidone Lurasidone 40 - 80mg flexible dose	Drug: Lurasidone Lurasidone 40-80 mg taken orally taken once daily

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566162

Contacts

Contact: Study Manager

1-866-503-6351

Show 68 Study Locations

Sponsors and Collaborators

Sunovion

Investigators

Study Director:

Lurasidone Medical Director, MD

Sunovion

More Information

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT01566162 History of Changes
Other Study ID Numbers:	D1050307, 2011-004790-90
Study First Received:	March 27, 2012
Last Updated:	May 21, 2013
Health Authority:	United States: Food and Drug Administration Bulgaria: Bulgarian Drug Agency Croatia: Ministry of Health and Social Care Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) India: Drugs Controller General of India Italy: The Italian Medicines Agency Poland: The Central Register of Clinical Trials Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control South Africa: Medicines Control Council Ukraine: Ministry of Health

Keywords provided by Sunovion:

Lurasidone
Latuda
Schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013