Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy (how well the drug works; primarily through the time to relapse) of long-acting injectable paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over 24 months in the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.

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

Details

• Lead Sponsor: Janssen-Cilag International NV
• Treatments: Antipsychotic Agents; Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Have been meeting the diagnostic criteria for schizophrenia for 1 to 5 years before screening, and have a history of treatment with antipsychotics

• Have a history of two or more relapses requiring psychiatric hospitalization in the preceding 24 months, which may include the current acute episode

• Experiencing at screening an acute schizophrenic episode with a Positive And Negative Syndrome Scale (PANSS) total score at screening between 70 and 120, inclusive

• Be healthy on the basis of physical examination, medical history and vital signs performed at screening

• Woman must be postmenopausal (for at least 1 year) or surgically sterile or abstinent or be practicing an effective method of birth control, must agree to continue to use the same method of contraception throughout the study and must have a negative urine pregnancy test at screening

• be able to fill out questionnaires

• Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug

Exclusion Criteria:

• Patients that have never been treated with antipsychotics before

• Treatment resistant patient and/or currently (i.within the last 3 months) treated with clozapine

• Substance dependence within 6 months prior to entry and current intravenous drug use or abuse

• allergies, hypersensitivity, or intolerance to risperidone or paliperidone or excipients

• treatment with a long-acting injectable antipsychotic within three injection cycles prior to screening

• newly started psychotherapy program within the two months preceding the treatment phase baseline

• evidence of clinically significant hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances in the past 6 months (as determined by medical history, clinical laboratory or ECG results, or physical examination) that would increase the risk associated with taking study medication or would confound the interpretation of the study

• history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome

• involuntarily hospitalized patient

• pregnant or breast-feeding females