A Study of the Efficacy (Effectiveness) of Paliperidone Palmitate in the Prevention of Recurrence of the Symptoms of Schizophrenia.

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of paliperidone palmitate compared with placebo in the prevention of recurrence of the symptoms of schizophrenia and to assess the safety and tolerability of paliperidone palmitate in patients with stable and symptomatic schizophrenia. 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.
• Collaborator: Janssen-Cilag International NV
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

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

• have a PANSS score of <120

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

• and have resided at the same address for at least 30 days

Exclusion Criteria:

• Patients unable to provide their own consent

• have been involuntarily committed to psychiatric hospitalization

• have primary, active DSM-IV-TM diagnosis other than schizophrenia

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

• have a history of treatment resistance as defined by failure to respond to 2 adequate trials (minimum of 4 weeks at a therapeutic dose) of different antipsychotic medications

• have a history of any severe preexisting gastrointestinal narrowing or inability to swallow the medication whole with water

• have a history of neuroleptic malignant syndrome (NMS)

• are at significant risk of suicidal or violent behavior

• current presence of any significant or unstable medication condition

• treatment with any protocol disallowed therapies

• clinically significant result from screening laboratory or ECG.