An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to explore the maintained efficacy, tolerability, and safety of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with other oral atypical antipsychotic medication.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Taiwan Ltd
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia

• Participant has been given an adequate dose of an appropriate oral atypical antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication

• Participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

• Female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must also have a negative urine pregnancy test at screening

• Male or female, aged greater than or equal to 18 years

Exclusion Criteria:

• Participants on clozapine, any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months

• Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities

• Participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)

• Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)

• Participants with a current use or known history (over the past 6 months) of substance dependence except for nicotine, caffeine, and betal nut according to DSM-IV Criteria