The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of ER OROS paliperidone(3, 9, and 15mg/day) compared with placebo in subjects with schizophrenia. The efficacy response will be measured by the change in the Positive and Negative Syndrome Scale (PANSS) total score from start of treatment to the end of the double-blind phase.

Condition	Treatment or Intervention	Phase
Schizophrenia	Drug: Paliperidone	Phase III

Further Study Details: 

Expected Total Enrollment:  595

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

Criteria

Inclusion Criteria:

- Double-Blind Phase:

• Subject can be male or female
• Age must be between 18 and 65 years of age, both inclusive
• Subject must have been diagnosed with schizophrenia according to DSM-IV (295.10, 295.20, 295.60, 295.90) at least 1 year prior to screening
• Subject must have signed an informed consent document, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
• Subject must be experiencing an acute episode, with a total PANSS score at screening between 70 and 120 6.Female subjects of child-bearing potential must agree to use an acceptable form of contraception (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study, and must have a negative serum B-human chronic gonadotropin (B-hCG) pregnancy test at screening.
• Subject must agree to voluntary hospitalization for a minimum of 14 days
• Subjects must be willing and able to fill out self-administered questionnaires
• Subjects must be able to be compliant with self-administration of medication, or have consistent help/support available.

- Open-Label Phase

• Subject must have signed the Informed Consent Form for the open-label phase
• Subject must have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy
• Subjects and investigator must agree that open-label treatment is in the best interest of the subjects
• Female subjects of childbearing potential must agree to continue to use an acceptable form of contraception(e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) through the open label extension, and must have a negative urine pregnancy test at open-label baseline.

Exclusion Criteria:

- Double-Blind Phase:

• A DSM-IV axis I diagnosis other than schizophrenia
• A DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
• Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
• Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic(including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases
• History of tardive dyskinesia or neuroleptic malignant syndrome (NMS)
• Known allergic reaction(rash) to phenytoin, carbamazepine, barbiturates, lamotrigine
• Other significant and/or unstable systemic illnesses
• Allergy or hypersensitivity to risperidone, carbamazepine, barbiturates, lamotrigine
• History of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
• Inability to swallow the study medication whole with aid of water(subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile)
• Previous history of a lack of response (2 adequate trials) to any antipsychotic
• Exposure to an experimental drug or experimental medical device within 90 days before screening
• Significant risk of suicidal or violent behavior
• Female subjects who are pregnant or breastfeeding
• Alanine aminotransferase or asparate aminotranferase levels more than 2 times the upper limit of normal
• Other biochemistry, hematology, or urinalysis results that are not within the laboratory’s reference range, and that are deemed by the investigator to be clinically significant
• Use of beta-blockers (if used for any indication other than hypertension and still present at baseline)
• Injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
• Use of monoamine oxidase inhibitors within 4 weeks before screening
• Use of other antidepressants(unless subject has been on a stable dosage for at least 3 months prior to screening)or mood stabilizers(e.g. antiepilepics, lithium) within 2 weeks before screening
• Received electroconvulsive therapy within 3 months before screening
• Employees of the investigator or study center, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or family members of the employees or the investigator

-Open-Label Extension:

• Subjects believed by the investigator to be at significant risk for suicidal or violent behavior during the open-label extension
• Female subjects who become pregnant
• Subject who have received an injection of a depot antipsychotic since entry into the preceding double-blind phase

Vanina Popova, MD      00 32 1460 8082    vpopova@prdbe.jnj.com

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
Arkansas
      Summit Research Group, Little Rock,  Arkansas,  72211,  United States; Recruiting
Connecticut
      Yale Univ. School of Medicine, New Haven,  Connecticut,  06519,  United States; Recruiting
Illinois
      Rush University Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
Indiana
      Larue D. Carter Memorial Hospital, Indianapolis,  Indiana,  46222,  United States; Recruiting
Louisiana
      Brentwood Research Institute, Shreveport,  Louisiana,  71101,  United States; Recruiting
New York
      NYU School of Medicine, New York,  New York,  10016,  United States; Recruiting
North Dakota
      Odyssey Research Services, Bismarck,  North Dakota,  58501,  United States; Recruiting
Ohio
      Charak Clinical Research Center, Lyndhurst,  Ohio,  United States; Recruiting
Canada, Ontario
      Lakeridge Health Corp-Oshawa, Oshawa,  Ontario,  L1G 2B9,  Canada; Recruiting

Study ID Numbers:  R076477-SCH-305/705
Record last reviewed:  January 2005
Last Updated:  January 21, 2005
Record first received:  May 27, 2004
ClinicalTrials.gov Identifier:  NCT00083668
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08