The Effect of Paliperidone Palmitate in Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within three different group of schizophrenia patients.

Detailed Description
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In this study, the investigators are going to examine the effectiveness of paliperidone palmitate after changing from other antipsychotics. This study design is a Prospective Naturalistic Case Series Study. The effectiveness of paliperidone would be compared within three different groups of schizophrenia. Investigators would also assess the safety during 24 weeks follow up period.

Official Title
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The Effect of Paliperidone Palmitate in Schizophrenia: A Prospective Naturalistic Case Series Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: paliperidone palmitate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18   65 Patient with schizophrenia according to DSM-IV criteria Patient have signed on the informed consent, and well understood the objective and procedure of this study. PANSSS total score <120 each Score of disorganized thought, paranoia hallucinatory behavior, abnormal tbought contests < 16 three different groups ( other antipsychotics refractory schizophrenia patitents : CGI> 4 chronic akathisia : DIEPSS overall severity >1, at least 1 month lasting symptoms poor compliance schizophrenia : CRS <3) Competent patient who is manage to answer the questionnaires. In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study. Exclusion Criteria: No history of antipsychotics prescription History of NMS(Neuroleptic malignant syndrome) Allergic reaction or hypersensitive reaction of risperidone or paliperidone ER clozapine medication within 1 month before screening SSRI, MAOI, TCA medication within 2 months Lithium, valproic acid, carbamazepine, topiramate, lamotrigine medication starting within 2 months patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion current or previous history of drug depedence according to DSM-IV Pregnant or breast-feeding female patient Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion history of cardiac disease, which is related to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia) History of participating to other investigational drug trial within 1month prior to screening Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paliperidone palmitate<br>paliperidone palmitate | Drug: paliperidone palmitate<br>* paliperidone palmitate 150mgeq(1 day), 100mgeq(8days), 75mg(monthly)<br>* Other names: paliperidone palmitate(sustenna);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-S,I: Clinical Global Impression-Severity, Improvement |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS: Positive and Negative Syndrome Scale |  | 24 weeks | 
| CRS: Clinician Rating Scale |  | 24 weeks | 
| KDAI-10: Korean Drug Attitude Inventory-10 |  | 24 weeks | 
| SWN: Subjective Well-being Under Neuroleptic Treatment |  | 24 weeks | 
| DIEPSS: Drug-Induced ExtraPyramidal Symptoms Sclae |  | 24 weeks | 
| injection site pain -VAS: Visual Analog Scale |  | 24 weeks | 
| LUNSERS: Liverpool University Neuroleptic Side Effect Rating Scale |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Injection, Switch, Paliperidone, refractory, chronic akathisia, poor complianc