Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2004-07-01
• 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 injection 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 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients diagnosed with schizophrenia

• for at least 1 year before screening

• meet PANSS score criteria

• must agree to hospitalization for a minimum of 14 days

• body mass index (BMI) <35.0 kilogram (kg)/meter (m)2.

Exclusion Criteria:

• Patients who are involuntarily committed as in-patients

• have a DSM-IV Axis I diagnosis other than schizophrenia

• have a DSM-IV diagnosis of substance dependence within 3 months before screening (nicotine, caffeine dependence, and history of recreational use of marijuana are not exclusionary)

• have a decrease of >/=25% in the PANSS score between screening and predose

• previous lack of response to 2 adequate trials of antipsychotic treatment

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

• have severe gastrointestinal narrowing (pathologic or iatrogenic)

• current presence of any significant or unstable medication condition

• treatment with any protocol disallowed therapies

• clinically significant result from screening laboratory or ECG.