Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Patients who meet diagnostic criteria for schizophrenia according to DSM-IV for at least 1 year

• meet PANSS score criteria

• have body mass index (BMI) of >15.0 kilogram(kg)/meter (m)2.

Exclusion Criteria:

• Patients who have primary active DSM-IV Axis I diagnosis other than schizophrenia

• have a decrease of >/=25% in the PANSS score

• have DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation (nicotine and caffeine dependence are not exclusionary)

• have history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications

• have any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)

• have significant risk of suicidal, homicidal or violent ideation or behavior

• current presence of any significant or unstable medication condition

• treatment with any protocol disallowed therapies

• clinically significant result from screening laboratory or ECG.