A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia - R076477-SCH-302/702 (INT-1)
- Conditions
- Schizophrenia
- Registration Number
- EUCTR2004-000326-70-CZ
- Lead Sponsor
- Janssen-Cilag, Johnson & Johnson spol. s.r.o.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 105
The subjects must satisfy the following criteria to be enrolled in R076477-SCH-302:
·65 years of age or older
·The subject signed an informed consent document indicating that the subject understands the purpose of, and procedures required for, the study and is willing to participate in the study
·The subject signed an informed consent document indicating that the subject agrees or does not agree to participate in the pharmacogenomic portion of the study. A subject who does not agree to have a DNA sample collected is still eligible to participate in the main portion of the study
·DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening
·Total PANSS score at screening and baseline (Visit 2) between 70 and 120, inclusive
·Agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated
The final visit of the double-blind treatment phase (Visit 10) will serve as the first visit of the open-label treatment phase (Visit 101) A subject must meet the following criteria to continue in the open-label treatment phase of the study (R076477-SCH-702):
·Subject has completed 6 weeks of the double-blind treatment phase or finished at least 21 days and discontinued because of lack of efficacy
·Subject has signed the informed consent form for the open-label treatment phase
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
·A DSM-IV Axis I diagnosis other than schizophrenia
·A DSM-IV diagnosis of substance dependence within the 6 months before screening (nicotine and caffeine dependence are not exclusionary)
·Any medical condition that can potentially alter the absorption, metabolism, or excretion of the study drug 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 or paliperidone
·History of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
·Inability to swallow the study drug whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug, 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
·Alanine aminotransferase or aspartate aminotransferase 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method