The Effect of Paliperidone Palmitate in Schizophrenia (NCT01860781) | Clinical Trial Compass
CompletedPhase 4
The Effect of Paliperidone Palmitate in Schizophrenia
South Korea30 participantsStarted 2011-08
Plain-language summary
The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within three different group of schizophrenia patients.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 f…
What they're measuring
1
CGI-S,I: Clinical Global Impression-Severity, Improvement