Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone, Paliperidone extended-release (ER)
Eligibility Criteria
Inclusion Criteria:
- Participant diagnosed with schizophrenia
- Participant's previous treatment of schizophrenia is considered unsuccessful
- Participant is healthy on the basis of a physical examination and vital signs
- Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
- Be willing and able to fill out self-administered questionnaires
Exclusion Criteria:
- Have used clozapine or Risperdal CONSTA during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months
- Judged to be at high risk for adverse events, violence or self-harm
- Inability to swallow the study medication whole with the aid of water
- Pregnant or breast-feeding female
- History or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Paliperidone ER: Lack of efficacy
Paliperidone ER: Lack of tolerability, compliance or other
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.