Clinical trial NCT01566162: A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
Official title: A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Lurasidone
Latuda
Schizophrenia
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)
timeFrame: 12 weeks
measure: Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline to week 12 LOCF endpoint
measure: Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.
timeFrame: Baseline to week 12 LOCF endpoint
Secondary outcomes:
measure: Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score
timeFrame: Baseline to week 12 LOCF endpoint
measure: Short Form-12 Health Survey (SF-12)
timeFrame: Baseline to week 12 LOCF endpoint
measure: Modified Specific Levels of Functioning (SLOF) Total Score.
timeFrame: 12 weeks
measure: Brief Adherence Rating Scale (BARS)
timeFrame: 12 weeks
measure: Smoking Questionnaire
timeFrame: 12 weeks
measure: Intent to Attend Assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K and S Professional Research Services
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Inc.
state: Arkansas
city: Cerritos
country: United States
facility: Comprehensive Clinical Development Inc.
state: California
city: Downey
country: United States
facility: Diligent Clinical Trials
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research Center
state: California
city: Garden Grove
country: United States
facility: CNS Network
state: California
city: Los Angeles
country: United States
facility: AXIS Clinical Trials
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Pico Rivera
country: United States
facility: CNRI-Los Angeles. LLC
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacolgoy Clinical Research Insitute
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Kissimmee
country: United States
facility: Accurate Clinical Trials
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Comprehensive NeuroScience Inc.
state: Georgia
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Lousiana Clinical Research, LLC
state: Louisiana
city: Rockville
country: United States
facility: Center for Behavioral Health, LLC
state: Maryland
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Saint Louis
country: United States
facility: Psych Care Consultants Research
state: Missouri
city: Las Vegas
country: United States
facility: Robert Lynn Horne, MD
state: Nevada
city: Willingboro
country: United States
facility: CRI Worldwide LLC
state: New Jersey
city: Buffalo
country: United States
facility: Erie County Medical Center, Corp
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research Inc.
state: New York
city: Fresh Meadows
country: United States
facility: Comprehensive Clinical Development, Inc
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research
state: Oklahoma
city: Philadelphia
country: United States
facility: CRI Worldwide LLC at Kirkbride
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Austin
country: United States
facility: FutureSearch Clinical Trials LP
state: Texas
city: Dallas
country: United States
facility: FutureSearch Clinical Trials, LP
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Department of Psychiatry, University of Utah Health Sciences Center
state: Utah
city: Dole
country: France
facility: Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)
city: Toulon
country: France
facility: Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
city: Massa
country: Italy
facility: Dipartimento Salute Mentale ASL 1
city: Pisa
country: Italy
facility: A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4
city: Lipetsk
country: Russian Federation
facility: Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
city: Rostov-on-Don
country: Russian Federation
facility: Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'
city: St. Peterburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7")
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)
city: Belgrade
country: Serbia
facility: Military Medical Academy, Clnic for Psychiatry
city: Dusica
country: Serbia
facility: Institute of Mental Health
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac, Clinic for psychiatry
city: Nis
country: Serbia
facility: Clinical Centre Nis, Clinic for mental health protection
city: Novi Knezevac
country: Serbia
facility: Specialized hospital for psychiatric diseases "Sveti Vracevi"
city: Novi Sad
country: Serbia
facility: Clinical Centre Vojvodine, Clinic for Psychiatry
city: Bojnice
country: Slovakia
facility: Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie
city: Bratislava
country: Slovakia
facility: Psychiatricka ambulancia Mentum s.r.o.
city: Michalovce
country: Slovakia
facility: Psychiatricka nemocnica Michalovce n.o.
city: Rimavska Sobota
country: Slovakia
facility: PsychoLine s.r.o. Psychiatricka ambulancia
city: Roznava
country: Slovakia
facility: Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
city: Svidnik
country: Slovakia
facility: "Centrum zdravia R.B.K., spol. s.r.o.
city: Tygervalley
country: South Africa
facility: Cape Trial Centre
state: Western Cape
city: Bloemfontein
country: South Africa
facility: Research Unit, Department of Psychiatry Free State Psychiatric Complex
city: Pretoria
country: South Africa
facility: Denmar Hospital Consulting Rooms
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Lurasidone Medical Director, MD
role: STUDY_DIRECTOR
References: