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

NCT01566162 | Completed Phase 3 Results

• 2 other identifiers: D10503072011-004790-90
• Study Type: interventional
• Target: 191
• Locations: 7 countries
• Sites: 63

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.

Conditions

Schizophrenia

Keywords

Lurasidone; Latuda; Schizophrenia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score

  Baseline to week 12 LOCF endpoint

• Short Form-12 Health Survey (SF-12)

  Baseline to week 12 LOCF endpoint

• Modified Specific Levels of Functioning (SLOF) Total Score.

  12 weeks

• Brief Adherence Rating Scale (BARS)

  12 weeks

• Smoking Questionnaire

  12 weeks

Study Arms (1)

Lurasidone

EXPERIMENTAL

Lurasidone 40 - 80mg flexible dose

Drug: Lurasidone

Interventions

Lurasidone DRUG

Lurasidone 40-80 mg taken orally taken once daily

Lurasidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (63)

K and S Professional Research Services

Little Rock, Arkansas, 72201, United States

Location

Woodland International Research Inc.

Little Rock, Arkansas, 72211, United States

Location

Comprehensive Clinical Development Inc.

Cerritos, California, 90703, United States

Location

Diligent Clinical Trials

Downey, California, 90241, United States

Location

Synergy Clinical Research Center

Escondido, California, 92025, United States

Location

CNS Network

Garden Grove, California, 92845, United States

Location

AXIS Clinical Trials

Los Angeles, California, 90036, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

CNRI-Los Angeles. LLC

Pico Rivera, California, 90660, United States

Location

California Neuropsychopharmacolgoy Clinical Research Insitute

San Diego, California, 92126, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Collaborative Neuroscience Network

Torrance, California, 90502, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34208, United States

Location

Accurate Clinical Trials

Kissimmee, Florida, 34742, United States

Location

Galiz Research

Miami Springs, Florida, 33166, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Comprehensive NeuroScience Inc.

Atlanta, Georgia, 30328, United States

Location

Lake Charles Clinical Trials, LLC

Lake Charles, Louisiana, 70601, United States

Location

Lousiana Clinical Research, LLC

Shreveport, Louisiana, 71104, United States

Location

Center for Behavioral Health, LLC

Rockville, Maryland, 20850, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

Psych Care Consultants Research

St Louis, Missouri, 63128, United States

Location

Robert Lynn Horne, MD

Las Vegas, Nevada, 89102, United States

Location

CRI Worldwide LLC

Willingboro, New Jersey, 08046, United States

Location

Erie County Medical Center, Corp

Buffalo, New York, 14215, United States

Location

Neurobehavioral Research Inc.

Cedarhurst, New York, 11516, United States

Location

Comprehensive Clinical Development, Inc

Fresh Meadows, New York, 11366, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Oklahoma Clinical Research

Oklahoma City, Oklahoma, 73116, United States

Location

CRI Worldwide LLC at Kirkbride

Philadelphia, Pennsylvania, 19139, United States

Location

Lincoln Research

Lincoln, Rhode Island, 02865, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

FutureSearch Clinical Trials LP

Austin, Texas, 78756, United States

Location

FutureSearch Clinical Trials, LP

Dallas, Texas, 75231, United States

Location

Pillar Clinical Research, LLC

Dallas, Texas, 75243, United States

Location

Department of Psychiatry, University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)

Dole, 39100, France

Location

Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)

Toulon, 83000, France

Location

Dipartimento Salute Mentale ASL 1

Massa, 54100, Italy

Location

A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4

Pisa, 56100, Italy

Location

Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'

Lipetsk, 398007, Russia

Location

Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'

Rostov-on-Don, 344000, Russia

Location

St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"

Saint Peterburg, 191167, Russia

Location

St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7")

Saint Petersburg, 190005, Russia

Location

St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1

Saint Petersburg, 19005, Russia

Location

St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)

Saint Petersburg, 191119, Russia

Location

Military Medical Academy, Clnic for Psychiatry

Belgrade, 11000, Serbia

Location

Institute of Mental Health

Dusica, 11000, Serbia

Location

Clinical Centre Kragujevac, Clinic for psychiatry

Kragujevac, 34000, Serbia

Location

Clinical Centre Nis, Clinic for mental health protection

Niš, 18000, Serbia

Location

Specialized hospital for psychiatric diseases "Sveti Vracevi"

Novi Kneževac, 23330, Serbia

Location

Clinical Centre Vojvodine, Clinic for Psychiatry

Novi Sad, 21000, Serbia

Location

Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie

Bojnice, 972 01, Slovakia

Location

Psychiatricka ambulancia Mentum s.r.o.

Bratislava, 82007, Slovakia

Location

Psychiatricka nemocnica Michalovce n.o.

Michalovce, 071 01, Slovakia

Location

PsychoLine s.r.o. Psychiatricka ambulancia

Rimavská Sobota, 97901, Slovakia

Location

Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie

Rožňava, 048 01, Slovakia

Location

"Centrum zdravia R.B.K., spol. s.r.o.

Svidník, 089 01, Slovakia

Location

Cape Trial Centre

Tygervalley, Western Cape, 7530, South Africa

Location

Research Unit, Department of Psychiatry Free State Psychiatric Complex

Bloemfontein, 9300, South Africa

Location

Denmar Hospital Consulting Rooms

Pretoria, 0081, South Africa

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director CNS Clinical Trials
• Organization: Sunovion

clinicaltrialdisclosure@sunvion.com

1-866-503-6351

Study Officials

• Lurasidone Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 9, 2019
• Results First Posted: November 20, 2014

Record last verified: 2019-04

Locations

US (38); FR (2); ZA (3); IT (2); SE (6); SL (6); RU (6)