A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone ER
Intervention description: Paliperidone Extended Release (ER) 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone extended-release tablets

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.
    

Eligibility 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