A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Subjects With Schizophrenia - Safety and tolerability of paliperidone palmitate in schizophrenia - deltoid vs gluteal injection.
Phase 1
- Conditions
- Schizophrenia according to DSM-IV-TM [disorganized type (295.10), catatonic type (295.20), paranoid type (295.30), residual type (295.60) or undifferentiated type (295.90)]
- Registration Number
- EUCTR2005-001845-40-SK
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
Inclusion Criteria
18 or older; consented;stable schizophrenia (PANSS <=70);BMI>=17kg/m2;able to perform study requirements
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
Exclusion Criteria
psychiatric hospitalization in last 90 days;change in antipsychotic dose in last 45 days;active substance dependence;treatment resistance history;relevant history or currren significant or unstable systemic disease;severe allergy or hypersensitivity to study drug,treatment with disallowed meds
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