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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00101634

Collaborator

(none)

518

Enrollment

14.9

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Paliperidone palmitate	Phase 3

Detailed Description

Many patients with schizophrenia have difficulty adhering to a daily oral treatment regimen. Long-acting injectable (LAI) formulations may provide therapeutic plasma concentrations over several weeks, thereby eliminating the need for daily oral medication and making compliance easier. This is a randomized (patients will be assigned to different treatment groups based solely on chance), double-blind (neither the patient nor the physician will know if placebo or drug is being given and at what dose), placebo-controlled, parallel group, multicenter, dose-response study in adults who have schizophrenia. The study consists of a screening period of no more than 7 days and a 13-week double-blind treatment period. The screening period includes 4 days for tolerability testing, if necessary. In the double-blind treatment period, patients will be randomly assigned to 1 of 4 treatment groups (3 fixed doses of paliperidone palmitate or placebo) to receive 4 i.m. injections of paliperidone palmitate or placebo on Days 1, 8, 36, and 64. The study, including the screening period, will last approximately 14 weeks. Efficacy will be assessed throughout the study using the Positive and Negative Symptom Scale for Schizophrenia (PANSS), the Clinical Global Impression-Severity (CGI-S), and the Personal and Social Performance Scale (PSP). Safety will be evaluated throughout the study by monitoring adverse events, extrapyramidal symptom (EPS) rating scales scores, clinical laboratory test results; vital signs and body weight measurements; electrocardiograms (ECGs); and physical examination findings. In addition, the tolerability of injections will be assessed. ER OROS paliperidone 3 mg/day for 4 days. Injections (i.m.) of paliperidone palmitate (25, 50, or 100 mg eq.) will be given on Days 1, 8, 36, and 64.

Study Design

Study Type:

Interventional

Actual Enrollment :

518 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq, 50 mg eq, and 100 mg eq) of Paliperidone Palmitate in Patients With Schizophrenia

Study Start Date :

Dec 1, 2004

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Change in total PANSS score from baseline to the end of the double blind treatment period. []

Secondary Outcome Measures

PSP and CGI-S scores from baseline to the end of of the double-blind treatment. Incidence of adverse events, labs and ECGs throughout study. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.