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.
|
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
California
Clinical Innovations, Santa Ana, California, 92705, United States; Recruiting
Himasiri DeSilva, Principal Investigator
Comprehensive NeuroScience Inc, Cerritos, California, 90703, United States; Recruiting
David Sack, Principal Investigator
Florida
Berma Research Group, Hialeah, Florida, 33016, United States; Recruiting
Alfredo Pujol, Principal Investigator
Illinois
Mid America Psychiatric Consultants, Granite City, Illinois, 62040, United States; Recruiting
Asif Habib, Principal Investigator
Uptown Research Institute LLC, Chicago, Illinois, 60640, United States; Recruiting
John Sonnenberg, Principal Investigator
Louisiana
Brentwood Research Institute, Shreveport, Louisiana, 71101, United States; Recruiting
Guy Brannon, Principal Investigator
Missouri
MedClin Research Inc, St. Louis, Missouri, 63118, United States; Recruiting
Surrendra Chaganti, Principal Investigator
New Jersey
CNS Research Institute, Clementon, New Jersey, 08021, United States; Recruiting
Steven Glass, Principal Investigator
New York
Neurobehavioral Research Inc, Lawrence, New York, 11559, United States; Recruiting
Ronald Brenner, Principal Investigator
Oklahoma
IPS Research, Oklahoma City, Oklahoma, 73103, United States; Recruiting
Louise Beckett, Principal Investigator
Texas
Tri County MHMR Services, Conroe, Texas, 77304, United States; Recruiting
Irving Belz, Principal Investigator
Community Clinical Research, Austin, Texas, 78756, United States; Recruiting
David Brown, Principal Investigator
University Hills Clinical Research, Irving, Texas, 75062, United States; Recruiting
Mary Ann Knesevich, Principal Investigator
InSite Clinical Research, Desoto, Texas, 75115, United States; Recruiting
Raj Shiwach, Principal Investigator
More Information
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
Resources
- Ask NOAH About: Schizoaffective Disorder Fact Sheet (New York Online Access to Health, The New York Hospital Cornell Medical Center (NOAH))
- Ask NOAH About: Schizophrenia Fact Sheet (New York Online Access to Health, The New York Hospital Cornell Medical Center (NOAH))

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