A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01150448

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

212

Starts

2007-09-01

Expected to finish

2009-06-01

Last updated by the study team

2014-05-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Cerritos, California, United States
• Study site — National City, California, United States
• Study site — San Diego, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Aalst, Belgium
• Study site — Zagreb, Croatia
• Study site — Kuala Lumpur, Malaysia
• Study site — Leszno, Poland
• Study site — Lubliniec, Poland
• Study site — Poznan, Poland
• Study site — Torun, Poland
• Study site — Bratislava, Slovakia
• Study site — Michalovce, Slovakia
• Study site — Rimavská Sobota, Slovakia
• Study site — Gwangju, South Korea
• Study site — Incheon, South Korea
• Study site — Seoul, South Korea
• Study site — Badalona, Spain
• Study site — Barcelona, Spain
• Study site — Madrid, Spain
• Study site — Hualien City, Taiwan
• Study site — Kaohsiung City, Taiwan
• Study site — Tainan, Taiwan
• Study site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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