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Evaluate the Efficacy in the Prevention of Recurrence of the Symptoms of Schizophrenia - Article


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Schizophrenia

Schizoid personality disorder; Schizotypal personality disorder 




Clinical Trial: Evaluate the Efficacy in the Prevention of Recurrence of the Symptoms of Schizophrenia

This study is currently recruiting patients.

Sponsored by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Purpose

The purpose of this study is to evaluate the efficacy of paliperidone palmitate compared with placebo (sometimes called a sugar pill) in the prevention of recurrence of the symptoms of schizophrenia and to assess the safety and tolerability of paliperidone palmitate in subjects with stable and symptomatic schizophrenia.

Condition Treatment or Intervention Phase
Schizophrenia
 Drug: R092670
Phase III

MedlinePlus related topics:  Schizophrenia

Study Type: Interventional
Study Design: Prevention

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Meet the diagnostic criteria for schizophrenia according to DSM-IV-TM for at least 1 year before screening;
  • PANSS score of <120;
  • BMI > or equal to 15.0;
  • Effective birth control or postmenopausal for at least 2 years;
  • reside at the same address for at least 30 days

Exclusion Criteria:

  • subjects unable to provide their own consent;
  • involuntarily committed to psychiatric hospitalization;
  • history of any severe preexisting gastrointestinal narrowing or inability to swallow the medication whole with water;
  • female subjects who are pregnant, breastfeeding, or planning to become pregnant;
  • MAOI antidepressants;
  • hypersensitivity to egg yolks, soybean oil, phospholipids, and glycerol

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00111189


California
      Clinical Innovations, Santa Ana,  California,  92705,  United States; Recruiting
Debra Hoffmeyer  714-547-4100 
Himasiri DeSilva,  Principal Investigator

      Comprehensive NeuroScience Inc, Cerritos,  California,  90703,  United States; Recruiting
Steve Ingalls  562-924-4262 
David Sack,  Principal Investigator

Florida
      Berma Research Group, Hialeah,  Florida,  33016,  United States; Recruiting
Dalia Alvarez  305-702-9453 
Alfredo Pujol,  Principal Investigator

Illinois
      Mid America Psychiatric Consultants, Granite City,  Illinois,  62040,  United States; Recruiting
Susan Akins  618-876-7256 
Asif Habib,  Principal Investigator

      Uptown Research Institute LLC, Chicago,  Illinois,  60640,  United States; Recruiting
Blake Vaugh  773-989-9871 
John Sonnenberg,  Principal Investigator

Louisiana
      Brentwood Research Institute, Shreveport,  Louisiana,  71101,  United States; Recruiting
Vickie Strong  318-227-4565 
Guy Brannon,  Principal Investigator

Missouri
      MedClin Research Inc, St. Louis,  Missouri,  63118,  United States; Recruiting
Mary Poupard  314-614-1500 
Surrendra Chaganti,  Principal Investigator

New Jersey
      CNS Research Institute, Clementon,  New Jersey,  08021,  United States; Recruiting
Sandy Romano  856-566-9000 
Steven Glass,  Principal Investigator

New York
      Neurobehavioral Research Inc, Lawrence,  New York,  11559,  United States; Recruiting
Maureen Legaulat  516-295-7230 
Ronald Brenner,  Principal Investigator

Oklahoma
      IPS Research, Oklahoma City,  Oklahoma,  73103,  United States; Recruiting
Monica Bottoms  405-235-8188 
Louise Beckett,  Principal Investigator

Texas
      Tri County MHMR Services, Conroe,  Texas,  77304,  United States; Recruiting
Darlene Smith  936-525-2647 
Irving Belz,  Principal Investigator

      Community Clinical Research, Austin,  Texas,  78756,  United States; Recruiting
Sarah Fowler  512-323-2622 
David Brown,  Principal Investigator

      University Hills Clinical Research, Irving,  Texas,  75062,  United States; Recruiting
Brandy Castano  972-717-6262 
Mary Ann Knesevich,  Principal Investigator

      InSite Clinical Research, Desoto,  Texas,  75115,  United States; Recruiting
Susan Allen  972-283-6286 
Raj Shiwach,  Principal Investigator

More Information

Study ID Numbers:  R092670-PSY-3001
Record last reviewed:  May 2005
Last Updated:  May 17, 2005
Record first received:  May 17, 2005
ClinicalTrials.gov Identifier:  NCT00111189
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-24

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December 2, 2009



Page Updated: October 15, 2009
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