A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects with Schizophrenia
- Conditions
- SchizophreniaMedDRA version: 8.1Level: LLTClassification code 10039626Term: Schizophrenia
- Registration Number
- EUCTR2006-003560-62-FR
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
- Men or women, aged at least 18 years old
- Meet diagnostic criteria for schizophrenia according to DSM-IV (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening
- A total PANSS score between 60 and 120, inclusive, at screening and baseline
- Body mass index (BMI) of > (or equal) 17.0 kg/m²
- Female subjects must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study. Effective methods of birth control include contraceptive pills, coil, depot injection of gestagen, subdermal implantation, hormonal vaginal ring, and transdermal depot patches. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hCG) pregnancy test result at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
- Unable to provide their own consent or involuntarily committed to psychiatric hospitalization
- A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
- A decrease of > (or equal) to 25% in the total PANSS score between screening and baseline as calculated using the table provided by the sponsor
- A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
- History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
- Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI > 40 kg/m²) or other systemic disease
- History or evidence of clinically significant hepatic disease [including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the upper limit of normal] at screening
- Significant risk of suicidal or violent behavior, as clinically assessed by the investigator
- Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20% Intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, and glycerol)
- Have received an experimental drug or experimental biologic, or used an experimental medical device within 6 months before screening or participated in 2 or more clinical studies in the past year
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