An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, tolerability and safety of paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in the prevention of relapse in schizophrenia participants.

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

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Have a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)

• Have experienced an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120 inclusive, at Screening and Baseline

• Women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), practicing a highly effective method of birth control, if sexually active

• Men must be using a highly effective method of birth control and must not donate sperm during the study and for 3 months after receiving the last dose of study drug

• Be willing and capable to complete the questionnaires and able to take oral medications independently

Exclusion Criteria:

• Has drug dependence diagnosis according to DSM-IV (excluding nicotine and caffeine dependence) within 6 months before screening

• Participants with Crohn's disease and hepatic or renal diseases

• Has had relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular dysfunction), renal, hepatic, endocrine, or immunologic diseases

• Has had history of neuroleptic malignant syndrome (the disorder caused by antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)

• Has had known or suspected Stevens Johnson Syndrome (an immune disease with symptoms of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin, carbamazepine, barbiturates, or lamotrigine

• Had been treated with clozapine for treatment refractory or treatment resistant schizophrenia

• Has significant risk of suicide or homicidal behavior, or significant risk of deliberate self harm or harm to others

• Has taken isocarboxazid, phenelzine, selegiline and tranylcypromine within 4 weeks before screening

• Has received electroconvulsive therapy within 60 days before screening