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

Schizophrenia Clinical Trial

Official title:

A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566162
• Other study ID #: D1050307
• Secondary ID: 2011-004790-90
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2019
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lurasidone
Lurasidone 40-80 mg taken orally taken once daily

Locations

Country	Name	City	State
France	Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)	Dole
France	Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)	Toulon
Italy	Dipartimento Salute Mentale ASL 1	Massa
Italy	A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4	Pisa
Russian Federation	Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'	Lipetsk
Russian Federation	Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'	Rostov-on-Don
Russian Federation	St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"	St. Peterburg
Russian Federation	St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7")	St. Petersburg
Russian Federation	St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1	St. Petersburg
Russian Federation	St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)	St. Petersburg
Serbia	Military Medical Academy, Clnic for Psychiatry	Belgrade
Serbia	Institute of Mental Health	Dusica
Serbia	Clinical Centre Kragujevac, Clinic for psychiatry	Kragujevac
Serbia	Clinical Centre Nis, Clinic for mental health protection	Nis
Serbia	Specialized hospital for psychiatric diseases "Sveti Vracevi"	Novi Knezevac
Serbia	Clinical Centre Vojvodine, Clinic for Psychiatry	Novi Sad
Slovakia	Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie	Bojnice
Slovakia	Psychiatricka ambulancia Mentum s.r.o.	Bratislava
Slovakia	Psychiatricka nemocnica Michalovce n.o.	Michalovce
Slovakia	PsychoLine s.r.o. Psychiatricka ambulancia	Rimavska Sobota
Slovakia	Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie	Roznava
Slovakia	"Centrum zdravia R.B.K., spol. s.r.o.	Svidnik
South Africa	Research Unit, Department of Psychiatry Free State Psychiatric Complex	Bloemfontein
South Africa	Denmar Hospital Consulting Rooms	Pretoria
South Africa	Cape Trial Centre	Tygervalley	Western Cape
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Comprehensive NeuroScience Inc.	Atlanta	Georgia
United States	Community Clinical Research, Inc.	Austin	Texas
United States	FutureSearch Clinical Trials LP	Austin	Texas
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Erie County Medical Center, Corp	Buffalo	New York
United States	Neurobehavioral Research Inc.	Cedarhurst	New York
United States	Comprehensive Clinical Development Inc.	Cerritos	California
United States	FutureSearch Clinical Trials, LP	Dallas	Texas
United States	Pillar Clinical Research, LLC	Dallas	Texas
United States	Diligent Clinical Trials	Downey	California
United States	Synergy Clinical Research Center	Escondido	California
United States	Comprehensive Clinical Development, Inc	Fresh Meadows	New York
United States	CNS Network	Garden Grove	California
United States	Accurate Clinical Trials	Kissimmee	Florida
United States	Lake Charles Clinical Trials, LLC	Lake Charles	Louisiana
United States	Robert Lynn Horne, MD	Las Vegas	Nevada
United States	Lincoln Research	Lincoln	Rhode Island
United States	K and S Professional Research Services	Little Rock	Arkansas
United States	Woodland International Research Inc.	Little Rock	Arkansas
United States	AXIS Clinical Trials	Los Angeles	California
United States	Galiz Research	Miami Springs	Florida
United States	Synergy Clinical Research Center	National City	California
United States	Psychiatric Care and Research Center	O'Fallon	Missouri
United States	Excell Research, Inc.	Oceanside	California
United States	Oklahoma Clinical Research	Oklahoma City	Oklahoma
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	CRI Worldwide LLC at Kirkbride	Philadelphia	Pennsylvania
United States	CNRI-Los Angeles. LLC	Pico Rivera	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Center for Behavioral Health, LLC	Rockville	Maryland
United States	Psych Care Consultants Research	Saint Louis	Missouri
United States	Department of Psychiatry, University of Utah Health Sciences Center	Salt Lake City	Utah
United States	California Neuropsychopharmacolgoy Clinical Research Insitute	San Diego	California
United States	Neuropsychiatric Research Center of Orange County	Santa Ana	California
United States	Lousiana Clinical Research, LLC	Shreveport	Louisiana
United States	Collaborative Neuroscience Network	Torrance	California
United States	CRI Worldwide LLC	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  France,  Italy,  Russian Federation,  Serbia,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)	Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)	12 weeks
Primary	Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score	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.	Baseline to week 12 LOCF endpoint
Primary	Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.	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.	Baseline to week 12 LOCF endpoint
Secondary	Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score	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.	Baseline to week 12 LOCF endpoint
Secondary	Short Form-12 Health Survey (SF-12)	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.	Baseline to week 12 LOCF endpoint
Secondary	Modified Specific Levels of Functioning (SLOF) Total Score.	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.	12 weeks
Secondary	Brief Adherence Rating Scale (BARS)	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.	12 weeks
Secondary	Smoking Questionnaire	Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).	12 weeks
Secondary	Intent to Attend Assessment	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?"	12 weeks