A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone palmitate
Intervention description: Paliperidone palmitate aqueous suspension for injection 0.5, 1.0, 1.5 milliliter equivalent to 50, 100, 150 mg paliperidone respectively as intramuscular injection on Days 1, 8, 36 and 64.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone Palmitate; JNS010

Summary:

      The purpose of this study is to assess the pharmacokinetics (the study of the way a drug
      enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in
      participants with schizophrenia (psychiatric disorder with symptoms of emotional instability,
      detachment from reality, often with delusions and hallucinations, and withdrawal into the
      self).
    

Eligibility criteria:

        Inclusion Criteria

          -  Participants who have been diagnosed with schizophrenia in accordance with the
             diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th
             edition (DSM-IV)

          -  Participants may be inpatients or outpatients

          -  Participants who have been taking an oral antipsychotic medication for at least 28
             days before the date of informed consent

          -  Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or
             equal to 4 (moderate) at screening

          -  Participants who have taken risperidone by the start of investigational treatment and
             the record can be confirmed Exclusion Criteria

          -  Participants who have been diagnosed with a mental disease other than schizophrenia in
             accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental
             Disorders 4th edition (DSM-IV)

          -  Participants who have been diagnosed with substance-related disorders (except nicotine
             and caffeine dependence)

          -  Participants with complicated parkinson's disease (a progressive disorder of the
             central nervous system, seen usually in older persons, in which there is muscle
             weakness, trembling and sweating)

          -  Participants with a complication of or with a history of convulsive disease such as
             epilepsy (seizure disorder)

          -  Participants with a complication of or with a history of cerebro-vascular accident
             (stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking,
             confusion, sweating more than usual, increased heart rate or blood pressure, or muscle
             pain or weakness) or physical exhaustion associated with the state of dehydration
             (lose of water and minerals in the body) or malnutrition