Schizophrenia Clinical Trial
Official title:
An Open-Label, Long-Term, Multiple-Dose, Safety and Tolerability, Pharmacokinetic Study of 150 mg eq. Paliperidone Palmitate in the Treatment of Subjects With Schizophrenia
The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to document the pharmacokinetics of paliperidone following fixed multiple intramuscular injections of paliperidone palmitate 150 mg eq.
Status | Completed |
Enrollment | 212 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening - Have a body mass index (BMI) of >=17.0 kg/m2 at screening - Have a Positive and Negative Syndrome Scale (PANSS) total score of <=70 Exclusion Criteria: - Have a primary active DSM-IV Axis I diagnosis other than schizophrenia - Have a PANSS total score of >70 at screening - Have a PANSS score of >16 points on the sum of the following 4 items at screening and baseline: conceptual disorganization, suspiciousness/persecution, hallucinatory behavior, and unusual thought content - Have scores greater than 5 on any of the individual items of the PANSS at screening or baseline - Have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
United States, Belgium, Croatia, Korea, Republic of, Malaysia, Poland, Slovakia, Spain, Taiwan, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of patients experiencing treatment emergent adverse events | Screening (Day -21 to -1) to Day 372 (or at the time of early termination from the study) | No | |
Primary | Concentration of paliperidone in plasma from blood samples obtained from patients | Day 1 to Day 372 | No | |
Secondary | Changes in Sleep Visual Analog Scale (Sleep VAS) scores as an indicator of quality of sleep and daytime drowsiness | Day 1 to Day 372. | No | |
Secondary | Changes in Positive and Negative Syndrome Scale (PANSS) scores | Day 1 to Day 372. | No | |
Secondary | Change in Clinical Global Impression Severity of Illness (CGI-S) Scores as an indicator of overall clinical condition | Day 1 to Day 372. | No | |
Secondary | Changes in Personal and Social Performance Scale (PSP) Scores (measures personal and social performance in patients with acute symptoms of schizophrenia. Higher PSP scores indicate better personal and social functioning) | Day 1 to Day 372. | No |
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