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Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
This study is currently recruiting participants.
Verified by Dainippon Sumitomo Pharma America, March 2008
First Received: February 1, 2008   Last Updated: March 17, 2008   History of Changes
Sponsor: Dainippon Sumitomo Pharma America
Information provided by: Dainippon Sumitomo Pharma America
ClinicalTrials.gov Identifier: NCT00615433
  Purpose

Lurasidone HCl is a compond developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.


Condition Intervention Phase
Schizophrenia
Drug: Lurasidone HCl
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3 Randomized, Placebo-and Active Comparator Controlled, CLinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.

Resource links provided by NLM:


Further study details as provided by Dainippon Sumitomo Pharma America:

Primary Outcome Measures:
  • Change in total PANSS score from baseline to the end of the double blind treatment period. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGI-S from baseline to the end of the double-blind treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: January 2008
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lurasidone HCl
    40mg/day, 120mg/day, placebo or active comparator for 6 weeks (acute phase). Open label lurasidone for 6 months (extension)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent and aged between 18 and 75 years of age.
  • Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
  • Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
  • Able and agrees to remain off prior antipsychotic medication for the duration of study.
  • Good physical health on the basis of medical history, physical examination, and laboratory screening.
  • Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

  • Considered by the investigator to be at imminent risk of suicide or iinjury to self, others or property.
  • Any chronic organic disease of the CNS (other than schizophrenia).
  • Used investigational compound within 30 days.
  • Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615433

Contacts
Contact: Christina D Butler, MS, CCRA 201-228-8041 cbutler@dsp-a.com

  Hide Study Locations
Locations
United States, Arkansas
Woodland International Research Group, LLC Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Dahlia Distin            
Principal Investigator: Duong Nguyen            
United States, California
UCSD Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Barbara Galangue            
Principal Investigator: David Feifel            
Collaborative Neuroscience Network Inc. Recruiting
Torrance, California, United States, 90502
Contact: Miriam Urrutia            
Principal Investigator: Armen Goenjian            
Clinical Pharmacological Studies, Inc. Recruiting
Cerritos, California, United States, 90703
Contact: Eddie Reyes            
Principal Investigator: Madeleine Valencerina            
CNRI - San Diego, LLC Recruiting
San Diego, California, United States, 92126
Contact: Robert Perkovic            
Principal Investigator: Tram Tran-Johnson            
University of California at Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: January Linn            
Principal Investigator: Steven Potkin            
California Clinical Trials Recruiting
Paramount, California, United States, 92865
Contact: Jake Badolian            
Principal Investigator: Stephen Volk            
Excell Research Recruiting
Oceanside, California, United States, 92056
Contact: Joshua Watts            
Principal Investigator: Jelena Kunovac            
United States, Florida
CORE Research Inc. Recruiting
Maitland, Florida, United States, 32751
Contact: Clara M Trammo            
Principal Investigator: Richard Knapp            
Segal Institute for Clinical Research Recruiting
Aventura, Florida, United States, 33180
Contact: Alexander Gomez            
Principal Investigator: Scott Segal            
United States, Illinois
Uptown Research Institute, LLC Recruiting
Chicago, Illinois, United States, 60640
Contact: Gwen Jacobs            
Principal Investigator: John Sonnenberg            
United States, Louisiana
Brentwood Research Institute Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Jennifer Swanson            
Principal Investigator: Guy Brannon            
United States, Mississippi
Precise Research Center Recruiting
Flowood, Mississippi, United States, 39232
Contact: Tomika Smith            
Principal Investigator: Joseph Kwentus            
United States, Missouri
St. Louis Clinical Trials Recruiting
St. Louis, Missouri, United States, 63118
Contact: Denise Beale            
Principal Investigator: Ricky Mofsen            
United States, New Jersey
CRI Worldwide @ Lourdes Recruiting
Willingboro, New Jersey, United States, 08046
Contact: Susan Lanis            
Principal Investigator: Steven Glass            
United States, New York
Neurobehavioral Research Inc. Recruiting
Cedarhurst, New York, United States, 11516
Contact: Stacy Mercado            
Principal Investigator: Ronald Brenner            
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Raleigh, North Carolina, United States, 27603
Contact: McLean Kram            
Principal Investigator: John Gilmore            
United States, Tennessee
Vanderbilt Heart and Vascular Institute Recruiting
Nashville, Tennessee, United States, 37212
Contact: Claudia Diaz-Byrd            
Principal Investigator: Herbert Meltzer            
United States, Texas
Community Clinical Research, Inc. Recruiting
Austin, Texas, United States, 78754
Contact: Rey Rocha            
Principal Investigator: David Brown            
Claghorn-Lesem Research Clinic, Inc. Recruiting
Houston, Texas, United States, 77008
Contact: Debora Clay            
Principal Investigator: Michael Lesem            
Bulgaria, Bourgas
DDPDS 'Prof. Ivan Temkov' Not yet recruiting
Complex 'Lazur' - Park 'Ezero', Bourgas, Bulgaria, 8000
Contact: Loris Sayan            
Principal Investigator: Loris Sayan            
Bulgaria, Plovdiv
UMHAT 'Sveti Georgi' Not yet recruiting
15A, Vassil Aprilov Blvd., Plovdiv, Bulgaria, 4002
Contact: Valentin Akabaliev            
Principal Investigator: Valentin Akabaliev            
Bulgaria, Radnevo
State Psychiatric Hospital 'Dr. Georgi Kissiov' Not yet recruiting
1, Magda Petkanova Str., Radnevo, Bulgaria, 6260
Contact: Penka Grozeva            
Principal Investigator: Penka Grozeva            
State Psychiatric Hospital 'Dr. Georgi Kissiov' Not yet recruiting
1, Magda Petkanova Str., Radnevo, Bulgaria, 6260
Contact: Todor Tolev            
Principal Investigator: Todor Tolev            
Bulgaria, Stara Zagora
District Dispensary for Psychiatric Disorders - Stara Zagora Not yet recruiting
16, Armeiska Str., Stara Zagora, Bulgaria, 6000
Contact: Georgi Krastev            
Principal Investigator: Georgi Krastev            
Colombia, Barranquila S/N
CIPNA Centro de Investigaciones y Proyectos en Neurociencias Not yet recruiting
Calle 80#47-43 Consultorio 5C, Barranquila S/N, Colombia
Contact: Astrid Arrieta            
Principal Investigator: Astrid Arrieta            
Colombia, Bogota DC N/A
Instituto Colombiano del Sistema Nervioso Clinica Montserrat Not yet recruiting
Cundinamarca, Calle 134 #17-71, Bogota DC N/A, Colombia
Principal Investigator: Martha Alzate            
Colombia, Bogota S/N
Centro de Investigacion y Atencion para la Salud Mental Not yet recruiting
Calle 103A # 21-49, Bogota S/N, Colombia
Contact: Laura Giraldo            
Principal Investigator: Laura Giraldo            
Colombia, Risaralda S/N
Psynapsis Salud Mental, S.A. Not yet recruiting
Carrera 23 # 11-11, Risaralda S/N, Colombia
Contact: Dora Cardona            
Principal Investigator: Dora Cardona            
Former Serbia and Montenegro, Belgrade
Institute of Psychiatry Not yet recruiting
Pasterova 2, Belgrade, Former Serbia and Montenegro, 11000
Contact: Miroslava Jasovic Gasic            
Principal Investigator: Miroslava Jasovic Gasic            
Institute of Mental Health Not yet recruiting
palmoticeva 37, Belgrade, Former Serbia and Montenegro, 11000
Contact: Dusica Lecic Tosevski            
Principal Investigator: Dusica Lecic Tosevski            
Former Serbia and Montenegro, Kraqujevac
Clinical Centre Kraqujevac Not yet recruiting
Zmai Jovina 30, Kraqujevac, Former Serbia and Montenegro, 34000
Contact: Goran Mihajlovic            
Principal Investigator: Goran Mihajlovic            
India, ANDH PRAD
Vijayawada Institute of Mental Health and Neurosciences Not yet recruiting
Vijaywada, ANDH PRAD, India, 520002
Contact: Vishal Indla            
Principal Investigator: Vishal Indla            
India, Gujarat
Hospital for Mental Health - Dept of Psychiatry Not yet recruiting
Outside Delhi Gate, Shahibaug Road, Ahmedabad, Gujarat, India, 380004
Contact: Ajaykumar P Chauhan            
Principal Investigator: Ajaykumar P Chauhan            
SBKS Medical College and Hospital, Brij Psychiatry Hospital Not yet recruiting
Vadodara, Gujarat, India, 390001
Contact: Sandeep Shah            
Principal Investigator: Sandeep Shah            
India, Karna
Manipal Hospital - Dept of Neurology Not yet recruiting
Bangalore, Karna, India, 560017
Contact: Murali Raj S.G.            
Principal Investigator: Murali Raj S.G.            
JSS Medical College and Hospital - Dept of Psychiatry Not yet recruiting
Mysore, Karna, India, 570004
Contact: Sathyanarayana Rao            
Principal Investigator: Sathyanarayana Rao            
Justice K.S. Hedge Charitable Hospital Not yet recruiting
Mangalore, Karna, India, 574160
Contact: Sateesh Rao            
Principal Investigator: Sateesh Rao            
India, Mahara
Rajiv Gandhi Medical College & Chatrapati Shivaji Maharaj H Not yet recruiting
Thane, Mahara, India, 400065
Contact: Anukant Mittal            
Principal Investigator: Anukant Mittal            
Lithuania, Kaunas
Ziegzdriai Mental Hospital Not yet recruiting
Kaunas District, Kaunas, Lithuania, 53136
Contact: Valdone Matoniene            
Principal Investigator: Valdone Matoniene            
Lithuania, Klaipeda
Klaipeda Mental Hospital Not yet recruiting
Bangu Str., Klaipeda, Lithuania, 91251
Contact: Stanislava Grigorjeva            
Principal Investigator: Stanislava Grigorjeva            
Lithuania, Vilnius
Republican Vilnius Psychiatry Hospital Not yet recruiting
Parko 15, Vilnius, Lithuania, 11205
Contact: Valentinas Maciulis            
Principal Investigator: Valentinas Maciulis            
Peru, Lima
Hospital Nacional Guillermo Almenara Irigoyen Not yet recruiting
La Victoria, Lima, Peru, 03
Contact: Beltran Villareal            
Principal Investigator: Beltran Villareal            
Clinica de Especialidades Medicas Not yet recruiting
San Borja, Lima, Peru, 41
Contact: Zoila Pacheco            
Principal Investigator: Zoila Pacheco            
Clinica Baltazar Caravedo Not yet recruiting
Jr. Independencia 242, Lima, Peru, 09
Contact: Jesus Mendoza            
Principal Investigator: Jesus Mendoza            
Hospital Nacional Edgardo Rebagliati Martins Not yet recruiting
Jesus Maria, Lima, Peru, 11
Contact: Beatrice Macciotta            
Principal Investigator: Beatrice Macciotta            
Philippines
Davao Medical School Foundation Hospital Not yet recruiting
Davao City, Philippines, 8000
Contact: Agnes Padilla            
Principal Investigator: Agnes Padilla            
National Center for Mental Health Not yet recruiting
Mandaluyong City, Philippines, 1553
Contact: Efren Reyes            
Principal Investigator: Efren Reyes            
Makati Medical Center Not yet recruiting
Makati City, Philippines, 1229
Contact: Elizabeth Rondain            
Principal Investigator: Elizabeth Rondain            
Metro Psych Facility Not yet recruiting
Mandaue City, Philippines, 6014
Contact: Jacqueline Sy            
Principal Investigator: Jacqueline Sy            
Sponsors and Collaborators
Dainippon Sumitomo Pharma America
Investigators
Principal Investigator: John Sonnenberg Uptown Research Institute, LLC
  More Information

No publications provided

Responsible Party: Dainippon Sumitomo Pharma America, Inc ( Christina Butler/Associate Manager )
Study ID Numbers: D1050231
Study First Received: February 1, 2008
Last Updated: March 17, 2008
ClinicalTrials.gov Identifier: NCT00615433     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009