A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self) who were not satisfied with other prior antipsychotics (agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect; olanzapine, quetiapine and risperidone) they had been taking. The safety and tolerability of paliperidone ER tablets will also be assessed.

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

Details

• Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Participants meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis criteria of schizophrenia

• Participant receiving full course of treatment (6-8 weeks) at correct dose (dose range recommended by the instruction) of Risperdal, Zyprexa or Seroquel before enrollment, was poorly controlled and had to change medication because of unsatisfying efficacy, tolerability or safety issues, or other reason

• Participant in the non-acute phase during screening received treatment with any of above three antipsychotics within 4 weeks before enrollment and state of illness was relatively stable

• 7. 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. Effective methods of birth control include prescription hormonal contraceptives, contraceptive injections, intrauterine devices, double barrier method, contraceptive patch and male partner sterilization. Female participants must also have a negative urine pregnancy test at screening

• Participant willing to and who could complete questionnaire by himself

Exclusion Criteria:

• Participant receiving treatment with clozapine or risperidone microspheres for injection (Hengde) within 3 months before screening

• Participant having history of seizure except febrile convulsion (seizures that occur during a febrile episode [fever])

• Participant having refractory schizophrenia (previous treatment with unsatisfied efficacy of 2 or more than 2 kinds of antipsychotics with different chemical structure after adequate dose and duration)

• Participant receiving electric shock treatment within 1 month before screening

• Participant having serious, unstable physical diseases