The Effect of Paliperidone Palmitate in Schizophrenia (sustenna)

Seoul National University

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: paliperidone palmitate

Study type

Interventional

Funder types

Other

Identifiers

NCT01860781

R092670-SCH-4008

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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