The Effect of Paliperidone Palmitate in Schizophrenia

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Paliperidone Palmitate

Criteria

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